Senior Quality Engineer - Medical Device - Cherry Hill, NJPageGroup
Job Summary
- Join a cutting-edge medical technology environment
- Lead quality engineering activities across product development and validation.
About Our Client
This organization is a rapidly expanding medical‑technology innovator focused on developing life‑changing therapeutic solutions. Its teams are united by a shared purpose and a passion for engineering excellence. The culture encourages creativity, cross‑functional collaboration, and continuous learning. Employees thrive in a supportive, mission‑oriented environment designed to empower bold ideas. The company is committed to growth, inclusivity, and delivering meaningful impact to patients worldwide.
Job Description
- Lead quality engineering activities across product development, validation, and manufacturing
- Partner with R&D, manufacturing, and regulatory teams to ensure compliance with FDA and ISO standards
- Oversee risk management processes, including FMEA and hazard analysis
- Drive root cause investigations, CAPA activities, and nonconformance resolution
- Support internal and external audits and regulatory inspections
- Develop and improve quality systems, procedures, and documentation
- Analyze quality data to identify trends and implement corrective actions
- Mentor junior engineers and influence best practices across the organization
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- Bachelor's degree in Engineering or a related technical discipline
- Extensive experience in quality engineering within the medical device or regulated industry
- Strong knowledge of FDA regulations, ISO 13485, and quality system requirements
- Proven experience with CAPA, nonconformances, and risk management tools
- Familiarity with validation processes, including IQ/OQ/PQ
- Excellent problem-solving, analytical, and communication skills
- Ability to work cross-functionally in a fast-paced environment
- ASQ certification (CQE or similar) preferred
What's on Offer
- Competitive base salary aligned with experience.
- Comprehensive medical benefits with full employee and family coverage.
- Paid vacation, holidays, floating days, and sick time.
- 401(k) program with employer match.
- Annual performance bonus eligibility.
- A collaborative, inclusive culture that encourages innovation and personal growth.
