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Job Description As Quality Manager, you will be responsible for leading HYTORC's quality operations and supporting the continued development and effectiveness of the company's Quality Management System (QMS). This role will manage and support key quality functions, including Quality Engineering, Quality Control, Supplier Quality, Calibration, Document Control, Compliance, and related EH&S activities as assigned. The Quality Manager will help maintain compliance with ISO 9001:2015 and ISO 17025:2017 requirements, support customer, supplier, internal, and third-party audits, and drive practical improvements across manufacturing, distribution, assembly, machining, and final product verification activities. The ideal candidate will bring strong hands-on experience in quality systems for manufacturing and machining operations, from incoming material inspection through in-process controls, final inspection, and product release. Key Responsibilities Quality Systems & Compliance • Manage and continuously improve QMS processes, including internal audits, CAPA, calibration, complaints, inspections, risk management, and document control., • Serve as a key quality contact and support ISO Management Representative responsibilities as assigned., • Support notified body, customer, supplier, and third-party audits related to ISO 9001:2015, ISO 17025:2017, and other applicable requirements., • Maintain accurate compliance documentation and ensure procedures, work instructions, forms, and quality records are properly controlled and current., • Track and trend quality metrics; develop reports and dashboards to communicate performance, risks, and improvement priorities., • Support periodic Management Reviews by preparing QMS performance data, audit results, corrective action status, and quality trend information., • Ensure quality requirements are integrated throughout manufacturing, distribution, assembly, machining, and final product verification processes., • Verify QMS compliance through internal audits and ensure timely follow-up on findings, corrective actions, and effectiveness checks. Operational Quality & Performance • Collaborate cross-functionally with Engineering, Manufacturing, Machining, Assembly, Distribution, and Supply Chain to identify, contain, and resolve quality issues., • Lead root cause analysis and corrective/preventive action efforts to improve product quality, process capability, and customer satisfaction., • Manage quality requirements for incoming inspection, in-process inspection, dimensional inspection, assembly checks, calibration, and final product release., • Support production scale-up, new product introductions, and the implementation of new equipment with appropriate quality controls and validated processes., • Define, monitor, and report departmental KPIs; manage priorities, resources, equipment needs, and day-to-day quality workload., • Drive standardization of inspection methods, acceptance criteria, quality records, and nonconforming material processes., • Partner with internal teams to identify opportunities for continuous improvement and reduce repeat defects, rework, scrap, and supplier-related issues. Supplier Quality & Audit Support • Plan, support, and improve vendor and supplier audit activities to evaluate compliance with internal standards, contractual requirements, and applicable regulations., • Monitor supplier quality performance, incoming inspection trends, supplier corrective actions, and recurring nonconformances., • Work with Procurement and Supply Chain to support supplier qualification, corrective action follow-up, and supplier improvement initiatives., • Ensure supplier quality issues are documented, escalated, and resolved in a timely and effective manner. Team Leadership & Development • Lead, coach, and develop quality team members across assigned QC, QA, Compliance, Calibration, Document Control, and related functions., • Set clear expectations, priorities, and performance goals; promote accountability, follow-through, and timely issue resolution., • Support departmental training, onboarding, compliance awareness, and certification needs in partnership with HR and functional leaders., • Build a practical, results-oriented quality culture focused on prevention, problem-solving, data integrity, and continuous improvement. Safety, Regulatory & Sustainability Support • Support regulatory readiness and ongoing compliance with OSHA, UL, RoHS, REACH, Conflict Minerals, ISO standards, and other applicable requirements., • Support Safety Committee and EH&S activities as assigned and promote safe work practices within quality and operational areas., • Stay current with relevant industry standards and help prepare the organization for changing quality and compliance expectations., • Support sustainability and ESG-related data collection or reporting as it relates to quality, compliance, or operational performance. Issue Management & Communication • Manage escalated quality issues, audits, nonconformances, and product concerns with urgency, clarity, and professionalism., • Communicate quality risks, audit outcomes, corrective action status, and improvement plans to senior leadership and cross-functional stakeholders., • Use data, objective evidence, and sound judgment to support decisions and drive timely resolution of quality concerns., • Maintain discretion and professionalism when handling confidential information, audit findings, supplier performance, and employee-related matters. Required Qualifications • Bachelor's degree in Engineering, Quality Management, Manufacturing, or a related field; equivalent relevant experience may be considered., • 7+ years of quality experience within a manufacturing, machining, industrial, or related environment., • Minimum 3 years of experience leading, supervising, or managing quality personnel or cross-functional quality initiatives., • Hands-on experience with QMS processes, internal audits, CAPA, nonconforming material, inspection, calibration, document control, and management review activities., • Strong working knowledge of ISO 9001:2015; knowledge of ISO 17025:2017 strongly preferred., • Experience supporting customer, supplier, internal, and third-party audits., • Experience with CNC machining, precision assembly, dimensional inspection, and final product testing preferred., • ASQ certification such as CQE, CQA, or CMQ/OE preferred; ISO 9001 Lead Auditor certification preferred., • Working knowledge of OSHA, UL, RoHS, REACH, Conflict Minerals, and related standards preferred., • Strong command of MS Office Suite, ERP systems, document control systems, and quality data analysis tools; Minitab experience preferred. Key Competencies • Hands-on quality leader with strong operational discipline., • Clear, professional verbal and written communication skills., • Strong cross-functional collaboration and influencing skills., • Detail-oriented, process-driven, and accountability-focused., • Sound judgment and calm decision-making under pressure., • Strong problem-solving and root cause analysis capability., • Continuous improvement mindset using formal tools and techniques such as DMAIC, 5 Why, fishbone analysis, and corrective action methodology., • Ability to balance urgency, compliance, documentation discipline, and practical business needs. Cultural Fit & Leadership Expectations • Comfortable in a closely held, relationship-driven organization with direct interaction across leadership and operations., • Hands-on manager who is willing to engage at both the shop-floor and management levels., • Committed to transparency, accountability, process improvement, and long-term organizational success., • Able to build trust, reinforce standards, and support a culture of quality across departments., • Trusted to manage confidential information with discretion and professionalism. Salary Range: $150,000 – $180,000 annually Actual compensation will be determined based on experience, qualifications, and business needs. This position may be eligible for bonus and a comprehensive benefits package, including medical, dental, vision, 401(k), and paid time off.#ZRCompany DescriptionIndustry leader with great innovation.Industry leader with great innovation.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Job Overview: Geltrude & Company is seeking a highly motivated and detail-oriented Senior Auditor with 2-5+ years of experience to join our growing CPA and advisory firm in Clifton, NJ. In this role, you will lead audit engagements from planning through report issuance, work directly with clients across various industries, and help shape how our firm leverages technology and AI to modernize the audit process. We specialize in HUD multifamily housing, LIHTC partnerships, nonprofits, and employee benefit plan audits - giving you the chance to build deep expertise in specialized areas. This is an exciting opportunity for an experienced auditor eager to take real ownership of engagements, work side-by-side with leadership, and grow on a clear path to manager. Duties: • Lead and execute audit engagements for nonpublic companies, HUD multifamily entities, LIHTC partnerships, nonprofit organizations, and employee benefit plans (401(k)), • Plan and perform audits in accordance with AICPA standards (GAAS), GAGAS (Yellow Book), and Uniform Guidance (Single Audit) requirements, • Draft financial statements, footnotes, and management letters in accordance with GAAP, • Evaluate the effectiveness of internal controls and identify areas for process improvement, • Review and analyze financial statements to ensure accuracy and compliance with HUD, NJHMFA, and other regulatory reporting requirements, • Prepare detailed audit findings and recommendations that clearly communicate issues and proposed solutions to clients and firm leadership, • Review staff workpapers, mentor junior team members, and uphold quality control standards, • Work directly with clients - board members, executive directors, property managers, and CFOs - to address audit findings and resolve open items, • Help shape how the firm uses AI and automation across the audit practice Requirements: • 2–5+ years of audit experience under AICPA standards (private company, nonprofit, or governmental work), • Bachelor's degree in Accounting, • Strong working knowledge of GAAP, GAAS, and internal control assessment methodologies, • Thomson Reuters Engagement Manager experience preferred, • HUD, LIHTC, nonprofit, or Single Audit (Uniform Guidance) exposure strongly preferred, • Demonstrated expertise in financial statement preparation, audit report writing, and analytical skills, • Ability to manage multiple engagement deadlines simultaneously and prioritize effectively, • Excellent written and verbal communication skills with the ability to convey complex financial information clearly, • Curiosity about technology and AI in accounting is a big plus Join us as a Senior Auditor and leverage your expertise at a firm where your work has real impact, your voice is heard, and your career growth is supported. At Geltrude & Company, we value specialized technical expertise, smart use of technology, and a meaningful connection to the communities we serve. Company DescriptionGeltrude & Company is an extremely progressive, 50-person (and growing), full-service accounting firm in Clifton, New Jersey, just outside of New York City. Our focus is on the solution, not the problem. We think as entrepreneurs and view the world through the eyes of our clients. Those optics motivate us to hire the most qualified staff, provide extensive training, and support them in their commitment to excellence.Geltrude & Company is an extremely progressive, 50-person (and growing), full-service accounting firm in Clifton, New Jersey, just outside of New York City. Our focus is on the solution, not the problem. We think as entrepreneurs and view the world through the eyes of our clients. Those optics motivate us to hire the most qualified staff, provide extensive training, and support them in their commitment to excellence.

Job DescriptionTitle: HR Manager (Recruiting, Learning & Development, Culture & Social Compliance, HR Analytics) Reports to: Director of HR & GA Department: Human Resources Responsibility Summary: The HR Manager leads people-centered HR functions including Recruiting, Learning & Development (L&D), Organizational Culture & Engagement, Social Audit Readiness, and HR Analytics. This role takes ownership of designing and executing employee-facing programs, talent development initiatives, and compliance-driven operations — while overseeing day-to-day recruiting execution and collaborating closely with Payroll and HR Operations. A key focus of this role is building EWL's internal Talent Development Platform from the ground up: envisioning the framework, driving adoption, and measuring impact. The HR Manager also plays a critical role in the upcoming HR System Implementation — leading testing, UAT coordination, and functional verification to ensure a smooth rollout. This is a hands-on leadership role requiring high visibility, strong interpersonal skills, and the ability to translate strategy into practical, measurable HR outcomes. Responsibilities: The HR Manager is responsible for supporting the company's business events through a variety of tasks, including: Recruiting (Supervisory Leadership) • Oversee full-cycle recruiting operations, with day-to-day execution supported by the recruiting team, • Partner with hiring managers to define role requirements, set timelines, and ensure a consistent candidate experience, • Maintain compliant, well-documented hiring processes ready for internal and external review, • Continuously improve recruiting workflows, templates, and sourcing strategies, • Monitor recruiting KPIs and provide guidance and coaching to the recruiting team member(s)Talent Development Platform (New Initiative — High Priority), • Conceptualize, design, and launch EWL's internal Talent Development Platform, • Define the framework: career pathways, skill gap analysis, individual development plans (IDPs), and growth milestones, • Partner with department heads to align talent development goals with business priorities, • Drive platform adoption through internal communication, manager enablement, and employee engagement, • Track participation, progress, and outcomes; continuously refine the platform based on data and feedbackLearning & Development (L&D), • Design and lead internal learning programs, including:, • AI Representative Program (4–6 weeks online learning + application project), • Required trainings (Safety, Quality, Compliance, Digital Literacy), • Promote active participation and high completion rates across all training initiatives, • Maintain training records that meet internal and external audit standards, • Explore and integrate emerging learning tools and digital platformsHR System Implementation — Testing & Verification, • Serve as an active HR stakeholder in the upcoming HRIS implementation project, • Lead or coordinate User Acceptance Testing (UAT) for HR-related modules, • Verify that system functionality aligns with HR workflows, compliance requirements, and reporting needs, • Document test cases, findings, and sign-off approvals, • Partner with HR Ops, IT, and the HR Director to ensure a seamless go-liveOrganizational Culture & Engagement, • Lead employee engagement initiatives, internal campaigns, and recognition programs, • Plan and execute company events and culture-building activities, • Strengthen cross-departmental communication and collaboration, • Serve as a visible, approachable HR presence across the organizationSocial Audit Readiness & Compliance, • Ensure HR operations are audit-ready at all times, • Support and coordinate social audits (e.g., SMETA, QIMA, customer audits), • Prepare and maintain HR audit documentation: employee records, training logs, working hours, policies, • Partner with the HR Director on audit responses and corrective action plans (CAPA), • Drive sustainable corrective actions and ongoing compliance improvementsHR Process Collaboration & KPI Contribution, • Collaborate with the HR Director on efficiency and continuous improvement initiatives, • Work closely with Payroll and HR Operations team members, • Serve as first-level payroll approver (Manager), prior to Director final approval, • Support HR digital operations using ADP, SharePoint, and Groupware, • Contribute to HR KPI achievement across engagement, training, compliance, and efficiency Required Qualifications: • Bachelor's degree in Human Resources, Business, or related field, • 6+ years of progressive HR experience, • Hands-on experience in L&D program design, culture initiatives, or talent development, • Experience supporting social audits or labor/compliance reviews (e.g., SMETA, QIMA), • Strong interpersonal, communication, and facilitation skills, • Demonstrated ability to build and execute HR programs from concept to completion, • Experience leading or supervising HR team members, • Proficient in English and Korean Preferred Qualifications: • Experience designing or launching an internal talent development or career growth framework, • Involvement in HRIS implementation, UAT, or system migration projects, • HR Manager or Senior HR Generalist background, • Manufacturing, cosmetics, or quality-driven industry experience, • Familiarity with ADP Workforce Now or similar HRIS platforms, • Proficiency in Spanish (strongly preferred), • Outgoing, people-oriented personality suited for culture and engagement leadership Preferred Certifications (Nice to Have) HR & People Management • SHRM-CP, SHRM-SCP, PHR, or SPHR (HRCI), • CIPD Level 5 or aboveSocial Compliance & Audit, • SMETA / Sedex Auditor Training or equivalent, • SA8000 Internal Auditor, • ISO 45001 or ISO 14001 Internal AuditorLearning & Development / Digital HR, • ATD (APTD or CPLP), • Learning & Development or Instructional Design Certificate, • ADP Workforce Now Certification or equivalent HRIS certificationEquivalent hands-on experience may be considered in lieu of formal certifications. Key Competencies • Strategic thinking with hands-on execution capability, • Strong communication, influence, and facilitation, • High visibility and genuine approachability, • Program and platform building from the ground up, • Ownership, accountability, and follow-through, • Compliance and process-oriented mindset, • Data-driven approach to HR decisions Success Indicators • Smooth oversight of recruiting with strong team performance and hiring quality, • Successful launch and adoption of EWL's Talent Development Platform, • High training participation and completion rates across the organization, • Successful HR system implementation with clean UAT sign-off, • Social audit outcomes with minimal or no HR-related findings, • Positive employee engagement and culture feedback, • Measurable contribution to HR KPI achievement Why This Role Matters This is a role for someone who wants to build — not just maintain. You'll have the opportunity to shape how EWL develops its people, modernizes its HR systems, and strengthens its culture. You'll lead meaningful programs, drive real outcomes, and grow alongside a team that values both compliance and people. Pay Range: • Pay Range: $75,000 to $110,000 per year Benefits:, • Medical, Dental, Vision, • Life/AD&D Insurance, • PTO + Special Paid Leave for personal events, • Company Paid Holidays, • 401(k) with employer match, • Year-End Gift Powered by JazzHR eQ7weECOko

Certified Quality Auditor (CQA) or equivalent ISO 13485 Lead Auditor Certification preferred. Principal Quality Internal Auditor. The Principal Quality Auditor plays a vital role in leading and participating in internal and external audits within the medical device industry.

The GMP Quality Assurance Auditor will report to the Director of the Quality Assurance Department.This position will be focused on ensuring GMP compliance with regulatory authorities, driving and implementing the Company's compliance directives and supporting quality management systems to ensure com

Getinge is seeking a Principal Quality Internal Auditor in Wayne, NJ, to lead internal and external audits in the medical device industry. This role requires at least 7 years of quality auditing experience and expertise in ISO 13485 and 21 CFR Part 820.

A rapidly growing biopharmaceutical organization is seeking an experienced GCP Senior Auditor to support Quality Assurance programs across global clinical development and safety operations. The GCP Senior Auditor plays a key role in ensuring compliance with regulatory requirements, internal SOPs, an

The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. GCP Auditor, Quality Assurance. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners an

A prominent health care organization in New Jersey seeks a clinical documentation specialist responsible for ensuring accurate clinical documentation and efficient coding for home care staff.The ideal candidate will have a current NJ RN or PT license and three years of certified home care experience