Quality Engineer

Curt Koland, Inc.; San Francisco (CA); On-site; USD 94,050 - 141,550; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Disability insurance

401(k)

Job summary

A medical device company is seeking a Quality Engineer in the San Francisco Bay Area. The ideal candidate will have over 5 years of experience in the medical device industry, focusing on design controls, verification and validation processes, and quality documentation. This full-time role demands strong collaboration across teams to enhance product quality and outcomes. Competitive salary and benefits are offered.

Qualifications

• Minimum 5 years of experience in the medical device industry.
• Strong commitment to improving patient outcomes.

Responsibilities

• Drive innovative medical technologies.
• Author and approve documentation for quality activities.
• Collaborate with teams for product release decisions.

Skills

Design controls

Verification and validation (V&V)

Cross-functional teamwork

Documentation related to quality activities

Risk analysis processes

Knowledge of external standards

Education

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

Job description

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 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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