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Kailera Therapeutics · 6 hours ago

Associate Director, Device Quality Engineering (Drug Device Combination Products)

Greater Boston

Contract

Hybrid

Lead/Staff, Director/Executive

$160K/yr - $200K/yr

10+ years exp

Kailera Therapeutics is committed to developing therapies that enhance overall health and transform lives. They are seeking an experienced Associate Director of Device Quality Engineering to lead quality engineering activities for drug-device combination products, ensuring compliance with regulatory and quality standards throughout the product lifecycle.

BiotechnologyPharmaceuticalTherapeutics

H1B Sponsor Likely

Responsibilities

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

Qualification

Quality EngineeringDevice Quality SystemDesign ControlsStatistical AnalysisRegulatory StandardsVeeva QualityDocsVeeva QMSSix Sigma CertificationProject ManagementProblem SolvingCommunication Skills

Required

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

Preferred

Experience with combination product submissions (IND, NDA, BLA)

Six Sigma or ASQ certification

Familiarity with Human Factors Engineering and usability testing

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

Equity grants

Company

Kailera Therapeutics

Kailera Therapeutics develops next-generation injectable and oral therapies for chronic weight management.

Founded in 2024

Waltham, Massachusetts, USA

51-200 employees

https://www.kailera.com

H1B Sponsorship

Kailera Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (1)