Quality Assurance Engineer 4

About the role

The Quality Assurance Engineer 4 will lead the Non‑Conformance (NCE) program, ensuring product quality and regulatory compliance across manufacturing sites and contract partners. This senior position combines oversight of design transfer, change control, and supplier quality within a regulated medical‑device environment.

Key responsibilities

• Manage the NCE lifecycle, publish status reports, and chair MRB review board meetings.
• Mentor NCE owners through investigation, root‑cause analysis, documentation, and escalation.
• Develop and maintain manufacturing transition procedures, including design transfer, change control, and process validation.
• Act as subject‑matter expert for design transfer, ensuring seamless hand‑off from development to manufacturing.
• Establish quality oversight for internal contract manufacturers, monitor production metrics, CAPAs, complaints, and audit findings.
• Liaise between divisional QA and Supplier Quality Engineering for external contract manufacturers and OEMs.
• Support supplier onboarding, review Quality Agreements, and manage supplier‑related investigations and corrective actions.
• Carry out supervisory duties such as hiring, training, performance appraisal, and conflict resolution.

Required profile

• Bachelor’s degree in a technical field.
• 8+ years of experience, preferably in the medical‑device industry.
• Strong knowledge of design transfer, process validation, and change control in regulated environments.
• Analytical mindset for data‑driven decision making.
• Excellent written, verbal, and presentation skills.
• Proven ability to make independent decisions and prioritize work.
• Effective cross‑functional collaboration.

Required skills

• FDA Quality System Regulations (QSR)
• ISO 13485
• MDSAP
• Medical Device Directive (MDD) and Medical Device Regulation (MDR)
• Design transfer
• Process validation
• Change control
• Root‑cause analysis
• Non‑conformance management
• CAPA management
• Supplier quality management