In this role, The Sr Manager, Quality Engineering & Compliance is responsible for leading the sites Quality Engineering, Manufacturing Quality, and Quality Compliance functions. This role oversees engineering quality processes, design transfer, process validation, production quality oversight, customer complaints handling.
The position leads Quality Engineers for both design and operations and Quality compliance engineers and ensures that products, processes meet all applicable regulatory, customer, and corporate requirements. The Manager serves as a strong advocate for product and process quality across the full lifecycle – from design transfer and process validation through post-market surveillance.
This role works cross-functionally with Operations, Engineering, RA, Supply Chain, and external stakeholders, ensuring compliance with standards such as ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820, and applicable GMP requirements.
Essential Duties and Responsibilities
Quality Engineering & Manufacturing Oversight: Lead review and approval of technical and engineering documentation including: DMR, DHF elements, IQ/OQ/PQ, Process validations and qualifications, Product specifications. Risk management files (dFMEA/pFMEA), Test methods, protocols, reports, Design transfer documentation
Provide quality oversight for: New production line establishment Process validation activities Engineering changes (ECO/DCO), Software validations.
Oversee production quality controls including: Raw material approval, Calibration approval (including deviations), DHR and batch record review, Labeling release, Nonconformance management (NCMR)
Drive Right First Time and Cost of Poor Quality (CoPQ) initiatives.
Provide escalation support and structured problem-solving guidance.
Customer Complaints & Post-Market Surveillance: Lead the sites customer complaints handling process:
Investigation and root cause analysis, Risk-based evaluation, Corrections and corrective actions, RMA/RGA management, Oversee complaints trending and reporting.
Support RA in identification of Adverse Events and Hazardous Situations.
Ensure feedback loop into risk management files and process improvements.
Interface directly with customers regarding QA-related nonconformities and investigations.
Leadership & People Management; Set priorities and objectives for Quality Engineering and Compliance teams. Supervise day-to-day performance, training, and development.
Provide coaching on: Root cause analysis, Risk-based decision making, Regulatory interpretation, Technical problem solving, Ensure effective communication across functional and leadership levels.
Promote a strong Quality First culture throughout the organization.
Education
B.Sc. in Engineering, Science, Chemistry, Biology or related discipline (Relevant experience may be considered in lieu of degree)
Work Experience
8-10+ years of experience in Quality roles within Medical Device industry
Proven experience in:
Design controls
Process validation
Risk management
Customer complaints handling
Strong knowledge of: ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820
5+ years of people management experience, preferred experience of managing team leaders.
Preferred Experience with: MasterControl, SAP, SharePoint, Statistical tools, Proficient in Microsoft Office Suite
Preferred Knowledge, Skills and Abilities
Certified Quality Auditor – Advantage
Strong knowledge and understanding of FDAs 21 CFR Part 820, ISO13485, ISO9001, and other international regulations.
Familiarity with document management databases, particularly MasterControls and SAP.
Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
