Quality Manager needed at leading medical device organization located just north of Boston, MA. Must have quality engineering and leadership experience within highly regulated, complex manufacturing environments. APPLY NOW!
location: Lowell, Massachusetts
job type: Permanent
salary: $100,000 - 120,000 per year
work hours: 8am to 5pm
- Site level quality leadership
- Ensure adherence and compliance to the company's Quality Management System
- Drive continuous improvement initiatives
- Ensure that site regulatory registrations are established and maintained (ISO 13485, FDA, etc.)
- Act as site-level Champion for Quality Best Practices and GDP/GMP continuous improvement efforts.
- Provide oversight and ensure compliance in the following areas: Internal Auditing, Supplier Quality Management, Complaint Handling, Corrective and Preventive Actions, Nonconforming Materials Controls; and the tracking & reporting of associated metrics.
- BS in engineering or quality related discipline
- Relevant site-level quality engineering and quality leadership within heavily regulated environments; medical device strongly preferred
- Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR
- Quality certification(s) (e.g. ASQ CQT, QCI, etc.).
skills: - Comprehensive benefit package
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.