Job Details

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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 Design

• Industries

  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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