Quality Systems Specialist
17 days ago
Rochester
Turbett Surgical is seeking a detail-oriented, collaborative, and highly motivated Quality Systems Specialist to support and maintain the company's Quality Management System (QMS). Reporting to the VP Quality, Regulatory & Compliance, this role will play a critical part in ensuring compliance with applicable regulatory requirements, quality standards, and internal procedures while supporting continuous improvement initiatives across the organization. \n \n The Quality Systems Specialist will be responsible for administering key quality system processes, including document control, training management, corrective and preventive actions (CAPA), change control, complaints management, quality plans, QMS software validation, audit support, and associated quality records. This individual will work closely with Quality Assurance, Quality Control, Regulatory Affairs, Operations, and Engineering teams to ensure product quality, patient safety, and regulatory compliance. \n \n The successful candidate will possess strong organizational and analytical skills, experience working within a regulated medical device environment, and a commitment to maintaining the highest standards of quality and compliance. Experience utilizing electronic quality management systems, including Grand Avenue Software, is highly desirable. \n \n KEY RESPONSIBILITIES \n \n Quality Systems Administration \n\n • Maintain and support the company's Quality Management System (QMS) in accordance with FDA Quality System Regulations, ISO 13485, and other applicable standards.\n, • Manage controlled documents, records, forms, and procedures through established document control processes.\n, • Support training program administration, including training assignments, records maintenance, and effectiveness monitoring.\n, • Coordinate periodic review and revision of quality system procedures and work instructions.\n, • Support Management Review activities through data collection, metric reporting, and maintenance of quality records.\n\n \n CAPA, Nonconformance, and Change Control \n\n • Administer Corrective and Preventive Action (CAPA) processes, ensuring timely investigations, root cause analyses, action implementation, and effectiveness verification.\n, • Assist in the management of Nonconformance Reports (NCRs) and quality investigations.\n, • Facilitate change control activities and ensure appropriate assessments, approvals, and implementation documentation are completed.\n, • Support risk management activities associated with quality system changes and product quality issues.\n\n \n Complaints Management \n\n • Support the complaint handling process, including intake, documentation, investigation coordination, and closure activities.\n, • Ensure customer complaints are processed in compliance with applicable regulatory requirements and internal procedures.\n, • Collaborate with Regulatory Affairs, Operations, Engineering, Quality Assurance, and Quality Control teams during complaint investigations.\n, • Analyze complaint trends and support the identification of recurring issues requiring CAPA or process improvements.\n, • Maintain accurate complaint records and support complaint-related reporting activities.\n\n \n Audit & Compliance Support \n\n • Assist with internal audits, supplier audits, and external regulatory inspections.\n, • Participate in audit preparation activities and support responses to audit observations.\n, • Monitor compliance with internal procedures, quality system requirements, and regulatory expectations.\n, • Support inspection readiness initiatives across the organization.\n\n \n Quality Metrics & Continuous Improvement \n\n • Compile, analyze, and report quality system metrics and performance indicators.\n, • Monitor trends related to complaints, CAPAs, nonconformances, audits, and training compliance.\n, • Identify opportunities for process improvements and assist with implementation of corrective actions.\n, • Support continuous improvement initiatives that enhance product quality, operational efficiency, and customer satisfaction.\n\n \n Cross-Functional Collaboration \n\n • Partner with Quality Assurance, Quality Control, Regulatory Affairs, Operations, and Engineering teams to support quality objectives.\n, • Provide guidance to employees regarding quality system procedures and documentation requirements.\n, • Participate in cross-functional project teams as required.\n\n \n QUALIFICATIONS \n \n Required \n\n • Bachelor's degree in Quality, Engineering, Life Sciences, Biology, Healthcare, or a related field, or equivalent combination of education and experience.\n, • Minimum of 3 years of experience in Quality Systems, Quality Assurance, or a related quality role within a regulated industry.\n, • Experience working in a medical device, healthcare, pharmaceutical, or other regulated manufacturing environment.\n, • Working knowledge of Quality Management Systems (QMS) and applicable regulations and standards, including:\n, • ISO 13485\n, • FDA 21 CFR Part 820 / Quality Management System Regulation (QMSR)\n, • Good Manufacturing Practices (GMP)\n, • Experience supporting CAPA, document control, change control, audits, and training systems.\n, • Strong organizational, analytical, and problem-solving skills.\n, • Excellent written and verbal communication abilities.\n, • Proficiency with Microsoft Office applications.\n\n \n Preferred \n · Experience in a medical device manufacturing environment. \n · Quality Assurance experience supporting production, process controls, inspections, or product release activities. \n · Experience supporting complaint handling and complaint investigation processes. \n · Experience using Grand Avenue Software or other electronic Quality Management Systems (eQMS). \n · Experience with root cause analysis methodologies and continuous improvement tools. \n · Certified ISO 13485 Lead Auditor, Certified Internal Auditor, or equivalent auditing certification. \n · ASQ certifications such as: \n\n • Certified Quality Auditor (CQA)\n, • Certified Quality Engineer (CQE)\n, • Certified Quality Improvement Associate (CQIA)\n, • Certified Manager of Quality/Organizational Excellence (CMQ/OE)\n\n · Regulatory Affairs Certification (RAC) or other relevant medical device quality/regulatory certifications. \n · Experience participating in FDA inspections, ISO 13485 certification audits, or supplier audits. \n · Familiarity with risk management principles and ISO 14971. \n \n CORE COMPETENCIES \n \n The successful candidate will demonstrate: \n\n • Strong attention to detail and accuracy\n, • Knowledge of medical device quality and regulatory requirements\n, • Problem-solving and analytical thinking\n, • Root cause investigation skills\n, • Effective documentation and record management\n, • Organizational and project coordination abilities\n, • Cross-functional collaboration and teamwork\n, • Customer-focused mindset\n, • Continuous improvement orientation\n, • Ability to manage multiple priorities in a fast-paced environment\n\n \n MEASURES OF SUCCESS \n · Timely and compliant management of quality system processes. \n · Accurate and effective administration of CAPA, complaint, training, and change control systems. \n · Successful support of internal audits, external audits, and regulatory inspections. \n · Maintenance of audit-ready quality records and documentation. \n · Improvement in quality system performance metrics and compliance indicators. \n · Effective support of customer complaint investigations and resolution activities. \n · Contribution to continuous improvement initiatives that enhance product quality and customer satisfaction. \n \n REPORTING STRUCTURE \n \n Reports To: \n VP Quality, Regulatory & Compliance \n \n Travel: \n Up to 10% as required. \n \n \n \n Work Environment: \n Hybrid, Boston Metro or Rochester, NY Preferred \n \n Benefits. As a full-time employee, you will also be eligible to participate in our current benefits package, which consists of health and dental insurance, 401K plan and vacation policy as further laid out in Turbett Surgical’s Employee Handbook. \n \n Compensation Range: $65,000 - $100,000 \n \n The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, internal equity, and location. \n \n Turbett Surgical, inc is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship, or any other characteristic protected by federal, state or local law.