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Device Quality Engineer

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Kailera Therapeutics

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Location:
United States , Waltham

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

160000.00 - 200000.00 USD / Year
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Job Description:

We are seeking a highly skilled and experienced Device Quality Engineer to support the development, validation, and launch of pre-filled syringe and autoinjector-based drug-device combination products. This role is critical in ensuring that combination products meet regulatory, quality, and performance standards throughout the product lifecycle.

Job Responsibility:

  • Lead quality engineering activities for combination product development, including design controls per 21 CFR 820 and ISO 13485
  • Ensure appropriate quality oversight at vendors and approve Vendor GMP documentation
  • Drive risk management processes in accordance with ISO 14971, including hazard analysis, FMEA, and risk-benefit assessments
  • Apply statistical techniques to analyze design verification, validation, and manufacturing data (e.g., DOE, regression analysis, capability studies)
  • Collaborate cross-functionally with R&D, Regulatory Affairs, and Operations to ensure robust design and manufacturing processes
  • Manage quality oversight of Contract Manufacturing Organizations (CMOs) and Contract Test Labs (CTLs), including audits, investigations, and quality agreements
  • Support design transfer activities and ensure compliance with combination product regulations (21 CFR Part 4)
  • Author/review quality documentation including protocols, reports, specifications, and risk files
  • Participate in root cause analysis and CAPA investigations related to device performance and reliability
  • Implementation and management of Device Quality System Procedures
  • Managing/resolving device related product complaints
  • Support regulatory submissions by providing quality and risk documentation

Requirements:

  • 10+ years of experience in medical device or combination product quality engineering
  • Proven experience with pre-filled syringes and autoinjectors in a regulated environment
  • Deep understanding of design controls, ISO 14971, and statistical analysis tools (e.g., Minitab, JMP)
  • Experience working with CMOs and CTLs, including quality oversight and technical collaboration
  • Strong knowledge of applicable regulations and standards (21 CFR 820, ISO 13485, ISO 14971, EU MDR)
  • Proficient in Veeva QualityDocs and Veeva QMS
  • Proficient in Word, Excel, PowerPoint, and SharePoint
  • Excellent communication, problem-solving, and project management skills
  • Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, or related field

Nice to have:

  • Experience with combination product submissions (IND, NDA, BLA)
  • Six Sigma or ASQ certification
  • Familiarity with Human Factors Engineering and usability testing
What we offer:
  • Comprehensive health coverage
  • Flexible time off
  • Paid holidays
  • Year-end shutdown
  • Monthly wellness stipend
  • Generous 401(k) match
  • Tuition reimbursement
  • Commuter benefits
  • Disability and life insurance
  • Annual bonus opportunities
  • Equity grants

Additional Information:

Job Posted:
January 20, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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