Product Quality Engineer

Company: BioTalent Ltd
Location: Santa Cruz
Posted on: April 1, 2025

Job Description:

Job Title: Product Quality Design Engineer
Location: San Francisco Bay AreaPosition Overview:
We are seeking a highly motivated and detail-oriented Product Quality Design Engineer to join our team in the medical device industry. This role will focus on ensuring product quality throughout the design and development process, contributing to the creation of innovative, safe, and reliable medical devices. The ideal candidate will work cross-functionally with R&D, manufacturing, and quality teams to implement quality engineering principles and ensure compliance with applicable regulations and standards.Key Responsibilities:

• Collaborate with cross-functional teams to integrate quality into product design and development processes.
• Develop and maintain risk management files, including dFMEAs and pFMEAs, ensuring they comply with ISO 14971 and other applicable standards.
• Define and validate design requirements, ensuring product specifications meet user needs and regulatory expectations.
• Conduct design verification and validation activities, including protocol creation, test execution, and documentation.
• Perform root cause analysis and implement corrective actions for product or process issues.
• Develop and implement inspection and testing methods to ensure product quality during design transfer.
• Support Design History File (DHF) documentation and ensure it meets regulatory and quality requirements.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other relevant regulations and standards.
• Participate in design reviews, providing quality input to ensure risk-based decisions and compliance.
• Contribute to process validation activities, including IQ, OQ, and PQ.
• Support internal and external audits by providing design and quality documentation as needed.Qualifications:
  • Bachelor's degree in Engineering (Mechanical, Biomedical, or related field) or equivalent experience.
  • 3+ years of experience in quality or design engineering within the medical device industry.
  • Strong understanding of design control, risk management, and validation requirements in a regulated environment.
  • Proficiency in quality engineering tools and methodologies (e.g., FMEA, statistical analysis, root cause analysis).
  • Experience with CAD software and design verification/validation testing.
  • Knowledge of regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Excellent problem-solving skills and attention to detail.
  • Strong written and verbal communication skills and the ability to work effectively in a team environment.Preferred Qualifications:
    • Experience with Class II or III medical devices.
    • ASQ Certified Quality Engineer (CQE) or similar certification.
    • Familiarity with software validation and usability engineering principles.What We Offer:
      • Competitive salary and comprehensive benefits.
      • Opportunity to work on cutting-edge medical technologies.
      • A dynamic and collaborative work environment with a focus on professional growth.
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Keywords: BioTalent Ltd, San Francisco , Product Quality Engineer, Engineering , Santa Cruz, California