Quality Manager

  • location: Lowell, MA
  • type: Permanent
  • salary: $100,000 - $120,000 per year
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job description

Quality Manager

job summary:
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
education: Bachelors
 
responsibilities:
- 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.

 
qualifications:
- 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

#LI-MZ1


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.

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