Senior Quality Engineer Job at BioTalent, San Jose, CA

TTBJNmN2WXZKU0I5a0dzZVljaUlxY0JmVWc9PQ==
  • BioTalent
  • San Jose, CA

Job Description

Senior Quality Engineer – Class III Medical Device

Location: San Francisco Bay Area

Requirements:

  • 5 days a week onsite
  • No Sponsorship options

A leading Class III medical device company in the Bay Area is seeking a Senior Quality Engineer to drive quality assurance initiatives and ensure compliance with FDA, ISO 13485, and other regulatory standards. This role will focus on design control, risk management, CAPA, and process validation to support the development and manufacturing of life-saving medical technologies.

Key Responsibilities:

  • Lead quality engineering activities in product development, design control, and risk management.
  • Develop and execute process validations (IQ/OQ/PQ) and statistical data analysis.
  • Support CAPA investigations, root cause analysis, and continuous improvement efforts.
  • Ensure compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
  • Collaborate cross-functionally with R&D, manufacturing, and regulatory teams.

Qualifications:

  • Bachelor’s degree in Engineering or related field.
  • 5+ years of quality engineering experience in the medical device industry.
  • Strong knowledge of Class III medical devices, risk management, and validation.
  • Experience with design control, CAPA, and regulatory compliance.
  • ASQ CQE or Six Sigma certification is a plus.

This is an exciting opportunity to make a direct impact in a fast-paced and innovative environment. Apply today to be part of a mission-driven team!

Job Tags

Similar Jobs

UBREAKIFIX - Miamisburg

Cell Phone Repair Technician Job at UBREAKIFIX - Miamisburg

 ...Description Are you a tech enthusiast who loves tackling challenges? Come aboard the UBREAKIFIX team in Miamisburg, OH as a Cell Phone Repair Technician and set off on an exciting adventure in the tech realm. Join a group that cherishes innovation, collaboration, and... 

Intuit

Finance Leader-Tech Ecosystem Job at Intuit

 ...Overview The Technology Ecosystem Finance team is seeking a highly skilled and motivated Senior Finance Leader of Technology Investments FP&A. This leader will partner with the senior leaders across Technology and Finance to support strategic planning, forecasting and... 

Meijer, Inc.

Fashion Area Team Member Job at Meijer, Inc.

 ...delivering remarkable customer service by providing customers with exceptional product knowledge, efficient service and a friendly attitude. This entry level team member position will be exposed to a variety of r Team Member, Fashion, Customer Service, Grocery Meijer, Inc.

CV Organization

Entry-Level Financial Services Career - work from home (code 023) Job at CV Organization

 ...are interested and dont mind hard work. We are looking for entry-level team members. Experience in customer service or training will...  ...Benefit Representatives meet virtually with members of labor unions, credit unions, associations, and parent groups. You will review... 

Bayshore Residence and Rehabilitation Center

Certified Occupational Therapist Assistant (COTA) Job at Bayshore Residence and Rehabilitation Center

 ...dignity, and respect. Bayshore Residence and Rehabilitation Center is looking for a PRN Certified Occupational Therapist Assistant (COTA) to provide rehabilitation services to our residents! Responsibilities: Provide occupational therapy services to residents in...