Medical device quality engineer jobs in Clifton, New JerseyCreate job alerts

Job DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesSupervisory Responsibility; Direct reportsWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.Must have the ability to work in a team-oriented environment and with clients.Must be able to work during the weekend, holidays and as required by the company.Working EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.Must have the ability to work in a team-oriented environment and with clientsMust be able to work during the weekend, holidays and as required by the companyMust be able to handle the standard/moderate noise of the manufacturing facility 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 Our client in Fairfield, NJ is looking for a Validation Engineer for a Full time position. Pay is $80k-$95k annually DOE • Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred., • Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables., • Experience in the medical device/ (GxP) industry is required., • Validation (IQ, OQ, PQ) or PPAP (Production Part Approval Process) required, • Must have knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance Benefits: The company offers a competitive benefits package that includes medical, dental, vision, 401k, pet insurance, etc... Company DescriptionPrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.PrideStaff is a 16 time Best of Staffing Award Winning full-service staffing company.

Job Description Department: Quality Location: PTI Tech, Clifton NJ Reports To: Director of Quality Mission To uphold and advance the highest standards of quality across all stages of manufacturing—ensuring compliance with AS9100 and customer-specific requirements through robust documentation, risk management, and process validation. This role exists to proactively prevent quality issues, support internal and customer-facing investigations, and strengthen PTI’s reputation as a trusted partner for mission-critical components. Competencies – What This Person Must Be Standards-Driven: Understands and applies AS9100, ISO 9001, MIL-STD-1916 and customer-specific standards; ensures audits, validations, and ongoing operations meet all requirements. Root Cause Problem Solver: Leads investigations using 8D, 5 Whys, and Ishikawa methods to ensure sustainable corrective actions. Process Control Advocate: Uses SPC, PFMEA, control plans, and capability studies to ensure consistent, capable production. Metrics-Driven: Uses data analysis to monitor trends, reduce scrap, and eliminate recurrence of quality issues. Customer-Focused: Communicates clearly with aerospace, defense, and other high-stakes clients; drives issues to closure and delivers timely updates. Cross-Functional Collaborator: Partners with Engineering, Manufacturing, and Production teams to align on requirements, validate processes, and resolve issues quickly. Detail-Oriented: Manages documentation and compliance requirements with accuracy including FAIRs, PPAPs, CAPA records, SOPs, and quality alerts with full traceability. Self-Directed and Proactive: Takes initiative to identify and resolve quality risks without being prompted and with minimal supervision; follows through on actions with rigor and accountability. Key Responsibilities • Drive quality improvements through Gage R&R studies, Statistical Process Control (SPC), Six Sigma, and Lean Manufacturing tools., • Lead investigations into internal and external quality issues; document findings and ensure timely resolution., • Perform root cause analysis using structured problem-solving methods (8D, 5 Whys) and verify the effectiveness of corrective and preventive actions (CAPA)., • Coordinate timely responses to Supplier Corrective Action Requests (SCAR), Non-Conformance Reports (NCR), customer complaints, and quality-related queries., • Prepare and maintain First Article Inspection Reports (AS9102), Production Part Approval Process (PPAP-AS9145) documentation, and validation (IQ/OQ/PQ)., • Lead risk assessments (PFMEA) and develop control plans to mitigate quality risks., • Track and analyze defects and scrap data to identify trends and prioritize corrective actions., • Collaborate with manufacturing and engineering to improve processes and define inspection criteria., • Own inspection processes, including CMM (Zeiss – Calypso), OGP, and Keyence programming, as well as inspection fixture design (SolidWorks preferred)., • Oversee QC personnel training in partnership with manufacturing engineering to establish visual standards and develop work instructions., • Maintain SOPs, work instructions, inspection procedures, and training logs in compliance with AS9100., • ≥ 98% Quality Shipments, • ≥ 90% Gage R&R Pass Rate, • ≥ 1.33 Cpk for Stable Processes, • ≤ 3% Internal Scrap Rate on assigned processes, • ≥ 95% CAPA Effectiveness, • ≥ 95% On-Time Submission of FAIRs, PPAPs, SCAR’s, and CAPA’s, • Bachelor’s degree in Mechanical, Manufacturing, or a related Engineering field, • 3–5+ years of quality engineering experience in injection molding or precision manufacturing, • Working knowledge of AS9100, ISO 9001, and MIL-STD-1916, • Experience with FAIR, PPAP, SPC, PFMEA, control plans, and CAD (SolidWorks preferred), • Proficiency in statistical tools (Minitab, JMP, Excel) and QMS/ERP systems, • ASQ Certified Quality Engineer (CQE) or Six Sigma certification, • Experience in the defense, aerospace, or medical device industries, • Hands-on inspection experience, including CMM, optical, or non-contact methods, • Ability to stand and walk on the production floor for extended periods, • Capable of lifting up to 40 lbs and accessing production and inspection equipment, • Manual dexterity for handling tools, parts, and inspection equipment, • Visual acuity sufficient to read prints, inspect parts, and identify quality defects, • Manufacturing facility with exposure to injection molding machines, CNC equipment, and secondary operations, • Requires use of PPE, including safety glasses, gloves, and hearing protection, • Frequent collaboration with production, maintenance, and engineering teams on the floorCompany DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description We are seeking a detail-oriented and experienced Validation Engineer to join our Quality team. In this role, you will take the lead in validating equipment, software, and manufacturing processes to ensure compliance with internal procedures, FDA/ISO standards, and customer requirements. You will play a key role in developing validation strategies, executing protocols, and supporting continuous improvement initiatives in a fast-paced, highly regulated medical device manufacturing environment. What You’ll Do • Lead validation projects for CNC, robotic, and other manufacturing equipment., • Develop and execute validation documentation, including:, • Validation Master Plans (VMP), • User Requirement Specifications (URS), • Installation Qualification (IQ), • Operational Qualification (OQ), • Performance Qualification (PQ), • Conduct risk assessments, validation reviews, and change control activities., • Collaborate with cross-functional teams, customers, and suppliers to align on validation requirements., • Support continuous improvement and Lean initiatives to optimize equipment performance and reduce waste., • Maintain up-to-date knowledge of GMP, ISO 13485, and validation best practices., • Education: BS in Mechanical Engineering or related field (Master’s preferred)., • Experience: Minimum 3 years in validation engineering, with hands-on experience writing and executing IQ/OQ/PQ protocols., • Background in highly regulated industries; medical device experience and ISO 13485 exposure strongly preferred., • Familiarity with CNC and robotic manufacturing processes., • Strong understanding of measurement system analysis (e.g., Gage R&R) and statistical tools (MiniTab preferred)., • Knowledge of GMP, Lean, and Six Sigma (Green/Black Belt certification is a plus)., • Excellent communication skills with the ability to work across departments and with customers., • Be part of a company dedicated to producing high-quality orthopedic medical devices., • Work on cutting-edge machine validation projects with opportunities for growth and advancement., • Collaborative and supportive team environment. Work Location: Multiple locations Company DescriptionPhillips Precision, Inc. has been providing a long-term, rewarding career path in Medical Manufacturing for Over 50 Years. Medical manufacturing provides many benefits - including a stable industry, competitive salaries, hands-on access to the latest technologies and the pride of knowing that you're working on real, tangible products that improve the health and well-being of people young and old. We have a diverse multicultural staff with varied backgrounds which brings a broad spectrum of new ideas and perspectives. We also maintain a manufacturing culture of continuous improvements with LEAN manufacturing disciples. This means we work smart, and efficiently with the ability to create custom solutions for the customers we serve. Medical Manufacturing at Phillips Precision is exciting and rewarding, with access to the latest technology and a supportive workplace environment.Phillips Precision, Inc. has been providing a long-term, rewarding career path in Medical Manufacturing for Over 50 Years.\r\n\r\nMedical manufacturing provides many benefits - including a stable industry, competitive salaries, hands-on access to the latest technologies and the pride of knowing that you're working on real, tangible products that improve the health and well-being of people young and old.\r\n\r\nWe have a diverse multicultural staff with varied backgrounds which brings a broad spectrum of new ideas and perspectives. We also maintain a manufacturing culture of continuous improvements with LEAN manufacturing disciples. This means we work smart, and efficiently with the ability to create custom solutions for the customers we serve.\r\n\r\nMedical Manufacturing at Phillips Precision is exciting and rewarding, with access to the latest technology and a supportive workplace environment.

Job Description Job Title: Project Engineer Company: PTI Tech Location: Clifton, NJ (On-site) Industry: Manufacturing / Metal & Plastic Injection Molding Experience Level: Mid to Senior Level About PTI Tech PTI Tech is a leading provider of advanced manufacturing solutions, specializing in precision metal and plastic injection molding for the aerospace, medical device, industrial, and defense industries. We are growing our technical team and seeking a skilled and motivated Project Engineer to support innovative product and process development efforts. Position Summary PTI Tech has an immediate opening for a Project Engineer to support the design and development of new products, components, and advanced manufacturing processes. This position plays a key role in PTI’s R&D and production programs, working closely with the Engineering Manager and cross-functional teams. Responsibilities include initial concept design, 3D modeling, analysis, prototyping, process development, vendor coordination, and supporting the implementation of novel engineering solutions. The ideal candidate is passionate about mechanical design, manufacturing innovation, and automation. We’re looking for a hands-on engineer with strong problem-solving skills, project leadership experience, and the ability to work effectively in a fast-paced, team-oriented environment. Key Responsibilities Design & Development • Develop production processes, tooling, fixtures, and manufacturing cells with a focus on quality and repeatability., • Perform technical and requirements analysis, researching new materials, technologies, and processes., • Apply DFM to assess part moldability and recommend design improvements for injection molding (plastic, metal, ceramic)., • Lead engineering projects from concept through production, coordinating cross-functional teams and external partners., • Create and manage project timelines, task assignments, and deliverables., • Write detailed work instructions, set up manufacturing equipment, and establish standard operating procedures (SOPs)., • Design and implement automation processes to increase manufacturing efficiency and consistency., • Program and troubleshoot Universal Robots and Arburg robotic systems., • Design and develop custom end-of-arm tooling for robotic automation., • Integrate automation systems into production workflows and support new product introductions (NPIs)., • Support ongoing production by resolving technical issues and improving part quality., • BS or MS in Mechanical Engineering, Materials Science, or related field., • Proficiency in CAD design using SolidWorks., • 5+ years of experience in mechanical design and development of injection-molded or over-molded parts and assemblies., • Strong knowledge of DFM, injection molding (plastic/metal), tool and mold design, and automation integration., • Experience with machine shop processes: turning, milling, EDM, and CNC machining., • Fluent in interpreting engineering drawings and applying GD&T., • Strong project management and organizational skills., • Experience in aerospace, medical device, defense, or industrial sectors., • Familiarity with additive manufacturing., • Experience with process validation, lean manufacturing, and quality systems., • Program management experience is a plus. Company DescriptionEngineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it. PTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.Engineers. Injection molders. Makers. Problem solvers. We are PTI Tech. We are a dedicated team of the nation’s leading experts devoted to manufacturing excellence. We have perfected our craft over our rich 37-year history, and we continue to push the boundaries of what’s possible. If you can imagine it, we can build it.\r\n\r\nPTI Tech supports some of the world’s most innovative “technology-first” companies and institutions across mission-critical applications, from surgical instruments to fighter aircraft components. PTI Tech’s family-run, personalized small-business approach to quality, innovation, and service continues to earn awards and recognition from government and industry.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

The ideal candidate will apply in-depth knowledge of mechanical engineering principles, demonstrate leadership in complex design/re-design projects, and provide technical guidance to cross-functional teams and junior engineers. Understanding of regulatory requirements and document control systems (e

The ideal candidate will apply in-depth knowledge of mechanical engineering principles, demonstrate leadership in complex design/re-design projects, and provide technical guidance to cross-functional teams and junior engineers. Understanding of regulatory requirements and document control systems (e