Senior Quality Engineer, Medical Device

Bedford, Massachusetts, United States

Posted on 09/12/2019 by Shurig Solutions, Inc.

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Position Details




Healthcare / Medical Devices


Quality Assurance / Safety

Job Level:

Experienced Professional (Non-Manager)


Bachelor's Degree


$100-$125k base, bonus opportunity

Reference ID:


Our client is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing.  They are looking for a Senior Quality Engineer to join their Quality Team to support design, development, production and distribution for design controls, Test Method Validation, SPC, Materials Quality, V&V, process improvements and Risk Management

The Right Talent:

BS in Engineering or relevant field

7+ years of quality engineering experience in the medical device, pharma, biotech or a highly regulated industry

Experience with Design Controls, RM/DHF, dFMEA, pFMEA and/or Test Method Validation

Experience with RCA, SPC, NCMR and Auditing

Experience with Supplier, selecting Suppliers and Supplier Audits a plus

Strong Project Management skills

Experience with Technology transfer an added plus


Some travel required

Please no H1-B Visa Candidates

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