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Senior Quality Engineer - Medical Device - Voorhees, NJ

Michael Page International

  • Moorestown, New Jersey
  • 30+ days ago
  • $120,000–$140,000 Per Year
  • Full-time

Highlights

With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next-generation treatment solutions for chronic heart failure. The key responsibilities of the Senior Quality Engineer are: Lead risk management activities in accordance with ISO 14971 and applicable regulatory requirements (e.g., FDA, EU MDR).
Michael Page International

Numbers & Facts

LocationMoorestown, New Jersey
Job TypeFull-time
IndustryStaffing/Employment Agencies
Salary$120,000–$140,000 Per Year
Company Size10,000 employees or more
Websitehttps://www.michaelpage.ca/

Description

Senior Quality Engineer

My client is driven by a mission rooted in innovation, transparency, and patient benefit, the company emphasizes excellence in design, adherence to global regulatory standards, and the development of a collaborative, talent-focused workplace. With continued investment, substantial venture backing, and ongoing expansion of its technology platform, the organization remains at the forefront of advancing next-generation treatment solutions for chronic heart failure.

Job Description

The key responsibilities of the Senior Quality Engineer are:

  • Lead risk management activities in accordance with ISO 14971 and applicable regulatory requirements (e.g., FDA, EU MDR).
  • Develop, maintain, and continuously improve risk management files, including hazard analyses, FMEA/FMECA, and risk/benefit assessments.
  • Ensure alignment of risk documentation with design control processes and design history files (DHFs).
  • Support global regulatory submissions by providing risk management documentation.
  • Ensure compliance with relevant standards and guidelines, including ISO 14971, ISO 13485, IEC 62304 (as applicable), and regulatory expectations.
  • Participate in internal and external audits, including FDA and notified body inspections.

If interested, please apply using the link below. Qualified applicants will be contacted 24-48 hours upon submittal. 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

The successful Senior Quality Engineer will have:

  • Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
  • 5+ years of experience in Quality Engineering, Risk Management, or related roles within the medical device industry
  • Strong working knowledge of ISO 14971 and risk management principles.
  • Experience with risk analysis tools such as FMEA, fault tree analysis, and hazard analysis.
  • Familiarity with design controls, CAPA systems, and post-market surveillance processes.
  • Understanding of applicable regulatory frameworks (FDA 21 CFR Part 820, MDSAP).

What's on Offer

My client can offer the following:

  • Full Coverage Medical Benefits - Employee + family contribution is 100%
  • Paid Vacation, floating holidays, and sick time.
  • Paid Holidays
  • 401k Match (up to 6%)
  • Annual bonus eligibility

Contact Daniel Hall Quote job ref JN-062026-7035987

Job Summary

Sector: Engineering & Manufacturing

Sub Sector: Maintenance, Reliability

Industry: Industrial / Manufacturing

Location: Moorestown

Contract Type: Permanent

About Company

Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job. In Canada, we focus on recruiting for the following areas: Banking and financial services Digital and e-commerce Engineering and manufacturing Finance and accounting Human resources Information technology Marketing Oil and gas Procurement and supply chain Property and construction Sales An Established Brand The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry. A Market Leader The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world. Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.

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