Quality Systems and Compliance Manager
About The Position
The Quality Systems and Compliance Manager is responsible for developing, implementing, maintaining, and continually improving the Quality Management System (QMS) in accordance with ISO 9001:2015, ISO 13485:2016, applicable regulatory requirements, and EU Medical Device Regulation (MDR) 2017/745. The role provides leadership and oversight for quality assurance, regulatory compliance, risk management, supplier quality management, internal audits, corrective and preventive actions, complaint handling, post-market surveillance, and management review processes. The position ensures that products and processes consistently meet customer, statutory, regulatory, and organizational requirements while promoting a culture of quality, continuous improvement, and risk-based decision making. Assignments are complex and strategic, requiring independent judgment, technical expertise, and leadership across cross-functional teams. The successful candidate leads and develops Quality personnel and provides strategic direction and day-to-day oversight of Quality Assurance, Quality Control, Supplier Quality, Document Control, Internal Audit, Complaint Handling, and Quality Systems activities, as applicable. The role also interfaces with executive leadership on quality performance, regulatory risks, compliance status, and improvement initiatives. Candidates must be U.S. citizens or U.S. Persons, as defined in the posting.
Requirements
- Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, Manufacturing, or a related discipline.
- Minimum 5–10 years of progressively responsible experience in quality management within a regulated manufacturing environment.
- Strong knowledge of ISO 9001:2015 and ISO 13485:2016 requirements.
- Knowledge of EU MDR 2017/745 requirements and ISO 14971 risk management principles.
- Internal auditing experience to ISO 9001 and ISO 13485.
- Expertise in CAPA, root cause analysis, and risk management.
- Supplier quality management and auditing experience.
- Strong regulatory compliance and inspection-readiness skills.
- Experience with data analysis, statistical methods, and quality metric development.
- Effective leadership, communication, and organizational skills.
- Working knowledge of Lean Manufacturing, Six Sigma, or Kaizen.
- Knowledge of MS Office, Dynamics AX/CRM, and Power BI.
- Must be a U.S. citizen or U.S. Person as defined in the posting.
Nice To Haves
- Medical device industry experience.
- ISO 13485 lead auditor or internal auditor certification.
- ASQ Certified Quality Manager (CMQ/OE), Certified Quality Engineer (CQE), or equivalent certification.
- Experience supporting Notified Body, FDA, customer, and certification audits.
- Experience with MDR technical documentation, post-market surveillance, and supplier quality programs.
Responsibilities
- Establish, implement, maintain, and continuously improve the organization's QMS in compliance with applicable standards, regulations, and company requirements.
- Serve as management representative or designated quality leader, ensuring QMS processes are established, implemented, maintained, and reported to executive management.
- Monitor QMS performance through quality objectives, KPIs, trend analysis, and management review reporting; maintain controlled documented information and quality records.
- Ensure compliance with applicable medical device regulations, including EU MDR 2017/745, FDA Quality System Regulation as applicable, and other global regulatory requirements.
- Support regulatory inspections, notified body audits, customer audits, certification audits, and governmental inspections; support regulatory submissions and product registrations through QMS activities.
- Ensure quality system procedures support technical documentation, device lifecycle controls, vigilance reporting, and post-market surveillance requirements.
- Promote risk-based thinking and ensure quality activities incorporate risk management principles, including ISO 14971 where applicable; review quality risks and evaluate risk-control effectiveness.
- Establish and maintain quality plans, inspection strategies, acceptance criteria, validation activities, and process controls; ensure verification, validation, qualification, and monitoring activities are performed and documented.
- Review manufacturing, inspection, testing, and service processes for compliance, and support design reviews, verification, validation, and design transfer.
- Establish and maintain supplier qualification, monitoring, re-evaluation, approval, auditing, quality agreements, change notification, performance monitoring, and supplier corrective action programs.
- Oversee nonconformance management, root cause investigations, corrective and preventive actions, and effectiveness verification; ensure timely resolution of quality issues.
- Identify and monitor continuous-improvement initiatives using data and trend analysis, risk assessment, Lean principles, and process improvement tools; report results to leadership.
- Develop and maintain internal audit programs and coordinate internal, supplier, customer, and certification audits; ensure findings are investigated, corrected, and effectively closed.
- Prepare and present management review information covering audits, customer feedback, process and supplier performance, CAPA status, complaints, risk management, and regulatory compliance.
- Ensure complaints, feedback, returns, and field issues are evaluated and investigated; support complaint handling, vigilance and adverse-event reporting, and field corrective actions as required.
- Monitor product performance and post-market surveillance data, identify trends and improvement opportunities, and analyze and communicate customer satisfaction data to management.
- Ensure personnel are trained and competent, and promote awareness of quality policies, objectives, customer requirements, regulatory obligations, and MDR requirements.
- Mentor and develop quality personnel; provide leadership and direction to quality personnel and cross-functional teams.
- Develop departmental goals, budgets, resource plans, and improvement strategies; support business objectives while ensuring quality and regulatory compliance.
- Interface with executive leadership regarding quality performance, regulatory risks, compliance status, and improvement initiatives.
- Follow import/export requirements and consult facility import/export personnel as required.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
