Associate Director, Device Quality Engineering (Drug Device Combination Products)
Kailera Therapeutics, Inc.Waltham, Massachusetts, United States
Posted February 20, 2026
155000 - 190000 USD
Full Time
About the Company
We are a bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health.
Job Description
At Kailera, 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.
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
- 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
Benefits
- 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 and equity grants
