Role Overview:
You will lead all quality-related activities, ensuring our devices meet stringent regulatory and industry benchmarks. Maintaining ISO 13485 certification and other necessary standards will be central to your work, ensuring full compliance at every step.
Core Duties:
- Continuous Improvement: Enhance the Quality Management System (QMS) following ISO 13485 guidelines and relevant industry practices.
- Team Leadership: Guide and develop the compliance team, ensuring strong performance and ongoing professional growth.
- Cross-Department Collaboration: Work closely with various teams to ensure adherence to quality standards while fostering a cooperative, quality-first mindset.
- Audit Management: Lead internal and external audits to uphold certifications (ISO 13485, MDSAP, MDR) and meet regulatory demands.
- Supplier Oversight: Manage supplier quality, including conducting audits and tracking supplier performance.
- CAPA/NCR Management: Oversee non-conformance and Corrective and Preventive Actions (CAPA) programs, conducting root cause analyses and implementing corrective measures.
- Training Programs: Develop training initiatives to ensure all personnel are versed in GMP/GDP standards and company protocols.
- Batch Record Oversight: Ensure batch record reviews are thorough and compliant.
- Quality Metrics: Track key quality indicators (KPIs) to evaluate QMS effectiveness and identify areas for improvement.
- Customer Complaint Handling: Manage and resolve customer complaints, ensuring full regulatory compliance and thorough documentation.
- Document Control: Ensure all documentation is accurate and accessible, managing Engineering Change Orders (ECOs) and post-implementation tasks.
Qualifications:
- Bachelor’s degree in a science or engineering discipline.
- Minimum of 5 years in a quality management role, ideally within the medical device sector.
- Strong working knowledge of ISO 13485 and FDA standards.
- Demonstrated problem-solving and analytical capabilities.
- Proven leadership and communication skills.
- Familiarity with quality management systems/software.
- Ability to work quickly and make informed decisions under pressure.
- Certification in quality (e.g., CQE, CQA) is an advantage.
Perks:
- Competitive pay with potential bonuses based on performance.
- Health, dental, and vision benefits.
- Employer-matched retirement savings plan.
- Opportunities for skill development and career growth.
- A collaborative and forward-thinking workplace.