Senior Quality Assurance Engineer Job at BioTalent, Springfield, MA

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  • BioTalent
  • Springfield, MA

Job Description

Our client is seeking a Senior Quality Engineer to join their team and drive excellence in quality and compliance for class I-II medical devices. This role requires a strong background in global medical device regulations, including EU MDR and FDA requirements.

Key Responsibilities:

  • Ensure compliance with EU MDR, FDA 21 CFR Part 820, ISO 13485, and other global regulations.
  • Lead quality system improvements, including CAPA, audits, and process validation.
  • Provide regulatory guidance on design controls, risk management, and post-market surveillance.
  • Collaborate with cross-functional teams to ensure regulatory and quality compliance in product development and manufacturing.
  • Support internal and external audits, including FDA and notified body inspections.

Qualifications:

  • Bachelor’s degree in Engineering, Quality, or related field.
  • 5+ years of experience in medical device quality engineering.
  • Strong knowledge of EU MDR, FDA regulations, and ISO 13485.
  • Experience with risk management (ISO 14971), CAPA, and validation processes.
  • Excellent problem-solving and communication skills.

On Offer:

  • Onsite training and career progression - great chance for someone with management aspirations.
  • Competitive salary, bonus, and benefits.
  • Relocation bonus (if applicable).

This is a great opportunity to make a direct impact on patient safety and regulatory compliance in a growing, innovative medical device company.

Job Tags

Relocation bonus,

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