Senior Quality Engineer - Med Device - Northborough, MA
A fast paced and competitive work environment in a constantly evolving market
A client centric company that encourages creativity and growth professionally
About Our Client
Our client is a big name in medical device CMO in the New England Area. They are looking to expand their NPD and Sustaining teams rapidly.
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 key responsibilities of the Sr. Quality Engineer are
- You will partner with R&D, Operations and Procurement personnel to actively engineer quality and ensure compliance for raw materials, components, finished products etc., from suppliers.
- You will lead additions/deletions/changes to the status of suppliers on the Approved Supplier List, including supplier master file records.
- Injection Molding and Metrology validation activities
- Performing 3rd party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE).
The Successful Applicant
The succesful Sr. Quality Engineer will have
- Bachelor/Master in Engineering
- 5+ year's experience in either a Quality, NPI or Continuous Improvement function
- Experience in the Medical Device with working knowledge of ISO 13485, ISO 9001 and 21 CFR 820 Experience with quality systems, quality tools and methodologies
- Knowledge and direct experience with injection molding
- Strong APQP knowledge and experience with all aspects of supplier quality management: quality concepts/tools/methods (e.g. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures
- Experience working in a manufacturing engineering environment strongly preferred.
- Assertive and with the ability to think out of the box and adapt to commercial context
- Able to work independently and under pressure
What's on Offer
- Short Term & Long Term Disability
- Life Insurance
- Flexible Spending Accounts
- Company Holidays Vacation