Position Summary:
As the Quality Leader at our Instruments site, you will establish and maintain a strong Quality Management System (QMS) while fostering a culture of quality. You will collaborate with operations and engineering teams to ensure compliance, manage product quality, and oversee corrective actions, audits and product release processes. This role also involves leading the quality team and driving continuous improvement initiatives.
Key Responsibilities:
- Lead and manage the sites Quality Team.
- Oversee the development and maintenance of QMS, ensure regulatory compliance.
- Drive corrective and preventative actions (CAPA) and non-conformance (NC) processes.
- Conduct internal and external audits, addressing any findings.
- Monitor product quality through inspections, testing, and data analysis.
- Support change management and process validation activities.
- Report on quality metrics and product performance to management.
Qualifications:
- Bachelor’s degree in Engineering, Science or Business, or equivalent experience.
- At least 3 years experience in medical device manufacturing and 5 years in Quality Assurance.
- Proficiency in CAPA, root cause analysis, and quality system management.
- Leadership experience with a focus on quality culture and team development.
- Familiarity with FDA GMP, ISO QMS, and process validation.
Preferred:
- Master’s degree in Engineering, Science or Business.
- Lean Manufacturing or Continuous Improvement experience.
- ASQ certification and/or Lean Six Sigma certification.
Benefits:
We offer a competitive salary and comprehensive benefits, including health insurance, 401k with company match, paid time off, employee stock purchase plan, performance bonuses, and tuition reimbursement.
