Sr. Quality Engineer - (Failure Analysis) job in San Francisco, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is looking to hire a Senior Quality Engineer for a leading biotechnology company located in San Francisco, CA.

Job Responsibilities:

Create and support complaint handling program, including complaint analysis, investigation, and follow up
Support corrective and preventive action (CAPA) program
Lead failure analysis testing on electromechanical devices and generate robust complaint investigation reports
Provide leadership and supervision to failure analysis staff, junior engineers, and technicians
Assess complaint events for MDR and Vigilance reportability
File Medical Device Report (MDR) and Vigilant report with US FDA and European authorities
Support training program to communicate Quality System requirements to organization at all levels
Review and modify product designs and process documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and conformance to product and quality system requirements
Review and approve failure analysis investigation reports
Prioritize all activities related to failure investigations and reports approvals

Skills and Requirements:

BS or MS degree in Engineering (e.g., Mechanical, Biomedical or Electrical Engineering)
4+ years Quality Engineering experience in Quality Assurance or Product Development activities in medical device industry

If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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