Pharmaceutical Manufacturing- Sr Quality Engineer- Burlington, Ma
Job Description
- Develop and update risk management files for new processes and changes.
- Assist in validations for new and existing products, processes, and equipment.
- Lead NC / CAPA teams by creating corrective action plans and overseeing closure.
- Coordinate supplier quality management, including qualification and investigations.
- Manage batch record review and product disposition.
- Prepare for and support site-level audits.
- Apply problem-solving methods to resolve quality issues.
- Identify and implement continuous improvement opportunities.
- Collaborate with departments, vendors, and customers.
- Perform other Quality System duties as needed
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.
MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- 6+ years of experience in medical device
- Experience in an FDA regulated manufacturing or industrial environment.
- ISO 13485 Quality System
- Technical skills and experience related to process validation, statistical methods, and risk management.
- Six Sigma
- Can work in person
What's on Offer
competitive compensation package, room for growth, amazing team!
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