Hybrid – Bay Area, CA: Senior Quality Systems Engineer (231485)

Life Sciences & Technology | Quality Assurance & Quality Control
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Job Description:

Our client is seeking a Senior Quality Systems Engineer for a 3-6 month contract. The Senior Quality Systems Engineer will assist with the company’s CAPA Program. It is important that these individuals exemplify and carry knowledge of the full CAPA Program Process (from implementation of a CAPA to close of a CAPA and training/mentoring others). While guiding others through the CAPA process, the Sr Quality Systems Engineer will be utilizing best risk practice tools to assess CAPA’s. Root cause analysis will be performed by the CAPA owner and the Senior Quality Systems Engineer will work closely with the CAPA owner to guide them through the process to identify the best corrective & preventive action as well as the best track plan moving forward. Strong familiarity with quality tools and methodologies will be required (i.e., Is/Is Not Analysis, 5 Whys, Cause & Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.).

Daily functions will involve mentoring/providing guidance to CAPA owners while managing & tracking timelines. There will be bi-weekly reports to board members to discuss current ongoing CAPA processes, individual CAPA’s, when & why certain CAPA’s can’t meet deadlines and best action plans moving forward.

This resource will be providing consistent hand-holding, follow-ups and best practices being suggested. This person should have excellent communication skills and be able to talk to CAPA owners at Director-levels, as well as individual contributor levels. Another area of importance will be knowing when to escalate matters or CAPA’s. There will be heavy follow-ups and constant communication throughout the company.

 

Required Experience:

  • Medical Device experience required (product is an aquablation robotic system for BPH). Thorough understanding of QMS Regulations (QSR), ISO 13485, MDD, MDR, CMDR, PAL), GMP.

 

 

Hybrid – Bay Area, CA: Senior Quality Systems Engineer (231485)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
California

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