Quality Engineer

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.

~

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).

~

• 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

~

EDUCATION REQUIREMENTS

• Bachelor’s or Master’s degree in an engineering discipline or equivalent

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Quality Assurance, Engineering, and Design
• Industries Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Curt Koland, Inc. by 2x

Medical insurance

Vision insurance

Disability insurance

401(k)

Apply BELOW