Direct message the job poster from Curt Koland, Inc.
Curt Koland Recruiting is looking for candidates eager to drive innovative medical technologies and who have a strong commitment to improving patient outcomes. Our client is an expanding medical device company focused on the development of thoughtfully designed and expertly engineered products.
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We are looking for local, San Francisco Bay Area candidates only with 5+ years of experience in the medical device industry or a directly related field. Candidates must have US Work Authorization or be a US Citizen (No H-1B Visa transfers).
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- Demonstrated experience with design controls and active participation in design reviews
- Proficient in developing and reviewing verification and validation (V&V) protocols and reports
- Active contributor to cross-functional project teams, supporting product specification development
- Responsible for authoring and approving documentation related to design verification, validation, lot release testing, and other quality activities
- Assist in risk analysis processes and ensure risk management documents are current
- Collaborate with R&D, Operations, and Regulatory Affairs to coordinate the release or hold of materials identified as non-conforming (NCRs)
- Document nonconformances, including root cause analyses and corrective actions
- Serve as CAPA owner, conducting comprehensive root cause investigations and preparing corrective and preventive action plans
- Identify and implement quality improvements in manufacturing processes
- Possess foundational knowledge of relevant external standards
- Please note: This is not an entry-level position
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EDUCATION REQUIREMENTS
- Bachelor’s or Master’s degree in an engineering discipline or equivalent
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance, Engineering, and DesignIndustries
Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
Disability insurance
401(k)
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