Quality Assurance Manager - Westborough, United States - Primary Talent Partners

Description

Primary Talent Partners has an opportunity open with our client in the Westborough, MA area. This is a contract position with a duration of 6 months and potential for extension or conversion.

Pay Rate:
$52/hr - $57/hr

Schedule:
Normal business hours. M and F are from home, T, W, Th on-site (hybrid)


Job Description:
Execute the triage, investigation, and closure of product quality complaints.

Run trend reports and perform statistical analysis of trends to identify emerging issues across various product groups and provides analysis around failure mode signals.

Support in CHU complaint handling and QA product root cause investigations as deemed appropriate by management.

Support with tracking major issues and related corrective actions.

Works with R&D, Manufacturing Engineers, Product Managers and Supplier Quality to ensure robust triage of product complaints and associated investigations; responsible for documentation of objective evidence in QMS records.

Writes and reviews technical reports and investigation/CAPA memos which are communicated to customers.


Required Qualifications:
Bachelors degree required; additional training/education preferred through ASQ (or relevant society) and/or Masters level program.

Minimum 7 years relevant experience industry experience (e.g. GMP medical device, pharmaceutical) required.

Minimum 7 years relevant experience dealing with post market surveillance activities (complaint triage, investigations, CAPA, etc.).

Experience with cGMP and/or ISO 13485 including documentation, audit, and post market surveillance.

Demonstrated understanding and application of 21CFR Regulations with respect to Customer Complaints.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at

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