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Quality Assurance Analyst Jobs in New Jersey
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Senior Design Quality Engineer - Medical Device - Medford, 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. Job summary: Sector Engineering & Manufacturing Sub Sector Maintenance, Reliability Industry Industrial / Manufacturing Location Moorestown Contract Type Permanent.
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 Design 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.

The key responsibilities of the Senior Design Quality Engineer are:

  • Serve as the Quality representative on cross-functional product development teams.
  • Ensure compliance with design control procedures (e.g., FDA 21 CFR Part 820, ISO 13485).
  • Review and approve design documentation, including design inputs, outputs, verification, validation, and design transfer activities.
  • Support the development and maintenance of Design History Files.
  • Lead and support risk management activities in accordance with ISO 13485:2016, 21 CFR Part 820 and MDSAP
  • Facilitate risk assessments including FMEA/FMECA, hazard analyses, and risk/benefit evaluations.
  • Ensure risk controls are effectively implemented, verified, and documented
  • Collaborate with Manufacturing and Operations to ensure smooth design transfer and process readiness.
  • Review production specifications, process validations, and inspection criteria.
  • Support process validation activities and ensure quality requirements are maintained in production.

The successful Senior Design Quality Engineer will have:

  • Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).
  • 5+ years of experience in Design Quality, Quality Engineering, or related roles within the medical device industry.
  • Strong knowledge of design controls and product development processes.
  • Deep understanding of ISO 13485 requirements.
  • Experience with risk management standards (ISO 14971).
  • Familiarity with verification & validation methodologies and statistical analysis tools.
  • Experience with CAPA systems, change control, and document management systems.

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

  • 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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