Senior Quality Assurance Engineer Job at BioTalent, Santa Rosa, CA

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  • BioTalent
  • Santa Rosa, CA

Job Description

Sr. Quality Assurance Engineer – Medical Devices- Full Time Permanent - 5 Days Onsite

We are seeking a Sr. Quality Assurance Engineer to support product development and ensure design quality within a fast-paced, Class III medical device environment. This individual will play a critical role in risk management activities and design validation processes to support innovative cardiovascular technologies.

Key Responsibilities:

  • Lead and review risk management activities, including DFMEA.
  • Evaluate and approve design documentation throughout the development lifecycle.
  • Support design verification and validation, including test method validation.
  • Collaborate cross-functionally with engineering and manufacturing to ensure quality integration into design and production processes.
  • Investigate non-conformances and drive corrective/preventive actions.
  • Participate in internal audits and ensure compliance with quality system regulations.

Qualifications:

  • Bachelor’s degree in engineering, life sciences, or related field.
  • Minimum 5 years of experience in an FDA-regulated medical device environment.
  • Solid knowledge of design control, risk management, and validation (IQ/OQ/PQ).
  • Strong organizational and communication skills.

Job Tags

Permanent employment, Full time,

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