You will be leading the Quality team, ensuring compliance with Quality Management Systems and supporting engineering efforts in manufacturing and product development.
Key Responsibilities:
- Quality System Oversight: Manage and maintain compliance with internal Quality Management Systems and regulatory standards.
- Regulatory Compliance: Ensure organizational awareness of regulatory requirements and quality standards.
- Management & Reporting: Lead management reviews, report on Quality System performane, analyse metrics, and drive improvements.
- Quality Control: Supervise inspection activities, manage complaint analysis, and corrective/preventive actions.
- Leadership: Guide Quality staff and cross-functional teams throughout product development.
- Risk Management: Support risk assessments, process validations, and design changes.
- Audits & Certifications: Oversee external audits, regulatory certifications, and document control.
- Continuous Improvement: Lead initiatives to enhance Quality Management Systems and enforce cGMP standards.
Must Have:
- Bachelor’s degree in science or engineering with 7+ years in a regulated medical device environment.
- Knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, CAPA, and customer complaints.
- Experience with Class II/III medical devices and manufacturing process tools (FMEA, Risk Management, Process Validation).
Preferred:
- Quality certifications (ASQ, Lead Auditor).
- Strong leadership, audit management, and data-driven decision-making abilities.
