New · posted Oct 15
Celldex Therapeutics · Biotechnology
Associate Director, Quality Medical Device Engineer
- Hampton, NJ
- On-site
- Full-time
- Director
Closes Sep 8, 2027 · 328 days left
The role
The Associate Director, Quality Medical Device Engineer will lead quality oversight activities for drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems, and related medical device constituents. This position will partner closely with Technical Operations, Device Development, Regulatory Affairs, Clinical, Supply Chain, and external manufacturing partners to establish and maintain compliant quality systems and ensure the successful development and commercialization of combination products.
What you need
- Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related scientific discipline required. Advanced degree (MS or MBA) preferred.
- Minimum 10 years of experience in Quality Assurance, Quality Engineering, Medical Device Quality, or Combination Product Quality within the pharmaceutical, biotechnology, medical device, or combination product industry.
- Demonstrated experience supporting commercial or late-stage development combination products.
- Experience working with contract manufacturing organizations (CMOs) and device suppliers.
- Experience with injectable combination products, autoinjectors, prefilled syringes, wearable injectors, or drug delivery systems.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
- Experience supporting FDA, EMA, notified body, or international regulatory inspections.
- Experience with ensuring compliance with applicable combination product regulatory requirements, including 21 CFR Parts 4, 210, 211, 820, ISO 13485, ISO 14971 and other relevant regulations.
- Strong understanding of pharmaceutical GMPs and biologics manufacturing environments.
What you'll do
- Serve as the Quality lead and Subject Matter Expert (SME) for combination product and medical device constituent quality activities.
- Provide strategic oversight of combination product development programs from concept through commercialization.
- Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation (QMSR), applicable ISO standards, EU MDR requirements, and other relevant global regulations.
- Support implementation and maintenance of a compliant combination product quality system aligned with corporate quality objectives.
- Provide quality oversight for design control activities, including design planning, design inputs/outputs, verification, validation, transfer, and design changes.
- Review and approve design history file (DHF) documentation and associated quality records.
- Participate in design reviews and ensure appropriate risk-based decision making throughout product development.
- Ensure usability engineering and human factors considerations are incorporated into development activities as required.
- Lead and support risk management activities in accordance with ISO 14971.
- Review and approve risk assessments, hazard analyses, FMEAs, and risk management reports.
- Provide quality oversight of medical device suppliers, contract manufacturers, and combination product partners.
- Support supplier qualification, auditing, monitoring, and performance management activities.
- Review and approve supplier quality agreements and technical quality documentation.
- Drive resolution of supplier quality issues through robust investigation and corrective action processes.
Pay and benefits
$153,616 – $199,501 a year
Employer providedAnnual discretionary bonus
Long term incentive
401(k) with employer contribution
Health care and other insurance benefits
Paid holidays
Vacation and sick days
Where you'll work
Hampton, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Hampton, NJFrom the posting
About Celldex Therapeutics
About Celldex
Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.
Equal opportunity, accessibility and legal noticesCelldex Therapeutics's statements, word for word
The expected base salary for this position is: $153616.00 to $199501.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 16% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in New Jersey9 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $153,616 | — | $199,501 |
| New Jersey (middle half) | $177,000 | $209,000 | $210,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Celldex Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Celldex Therapeutics's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- GMP and compliance5
- Documentation and SOPs3
- Collaboration and leadership3
- Validation and qualification2
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Celldex Therapeutics on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 2
- Locations
By discipline
- Quality5 100%
By level
- Director2 40%
- Associate & Specialist2 40%
- Senior & Principal1 20%
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Associate Director, Quality Medical Device Engineer at Celldex Therapeutics
Applications close September 8. $154K–$200K a year, employer provided.