Design Quality Engineer

2 hours ago


Marlborough, United States BioTalent Full time

Summary:

This role ensures compliance with medical device regulations and supports the product development process. The focus is on product safety, quality, and compliance while maintaining a collaborative relationship with cross-functional teams. A strong electrical engineering background will be required for this position.

Responsibilities:

  • Oversee quality assurance in the product development lifecycle, including risk management, design verification, and validation.
  • Ensure compliance with regulatory standards (ISO 13485, 21 CFR Part 820, etc.).
  • Support the review and approval of design control documentation.
  • Perform supplier quality management tasks, including audits and performance monitoring.
  • Investigate product and process non-conformances; identify root causes and implement corrective actions.
  • Participate in regulatory inspections and audits.
  • Continuously improve quality systems and processes.

Qualifications:

  • Bachelor's degree in electrical engineering or a related field.
  • 3+ years of experience in quality engineering.
  • Strong knowledge of design control requirements and quality system regulations.
  • Strong knowledge of ISO 13485, ISO 60601, 21 CFR Part 820, and similar regulatory standards.



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