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QUALITY ENGINEER II

BERGEN COUNTY, NJ

Posted: 10/08/2025 Industry: ENGINEERING Job Number: 14681 Pay Rate: $90K - $95K ANNUALLY

Job Description

Our client is one of the global leaders in the medical device industry, seeking to hire a Quality Engineer II to join the team. The primary function of this position will review and process complaint records for assigned products which includes interacting with customers (internal and external) and maintaining associated records. Processing may include performing technical analysis of failed parts to determine root cause. The incumbent will support all quality system matters associated including, but not limited to internal/external audits, contract manufacturing, distribution and service related operations and CAPA. Hours are Monday - Friday, 8:30am to 5:30pm, after 2 months of training period hybrid schedule of 3/2 is offered. Company offers full comprehensive benefits package, health, dental, 401K, and PTO.

Responsibilities:
- Ensure the integrity and completeness of related complaint files
- Work with colleagues here and in China to perform root cause investigations on failed product
- Assist in other quality/regulatory related investigations where necessary (e.G. CAPA)
- Support all other quality related operations, as assigned (e.G. Project teams, operations support, etc.)
- Identify opportunities to ensure compliance with internal and external quality requirements
- Support internal/external audits
- Support definition and verification of Quality Management Software systems
- Reviews documentation supporting all aspect of quality/regulatory related functions
- Recommends alternative approaches to quality/regulatory processes

Job Requirements

Qualifications:
- Engineering Degree preferred, relate d field (science, software) considered
- Working knowledge of 21 CFR 820 medical device Quality Management Systems a plus
- 3 to 6 years of Quality Management Systems and/or Regulatory related experience desired
- Knowledge of 21 CFR 820 and ISO 13485, at a minimum related to complain handling
- Ability to work in a fast-paced environment, high output, team oriented environment
- Excellent organizational, analytical, and writing skills required
- Excellent computer skills, word processing, spreadsheets, etc

Meet Your Recruiter

Robert Bikofsky
Full Desk Recruitment Executive

Robert has gained the bulk of his professional experience within the hospitality/hotel management industry since 2008. Industry shifts post-Covid encouraged Robert to transition to the staffing/recruiting industry, joining the RJ-Staffing team in 2022. Along with him, he brought a host of relevant experience to the table, including hourly and salary personnel recruitment, staff supervision, and client experience management. As a Rockland County native, Robert takes pride in helping business and job-seekers in his hometown. When he’s not building relationships with businesses in need of recruiting support, listening carefully to our applicants career goals, or burning the midnight oil to maximize our firm's reach, you can find him rolling putts to sharpen his golf skills, taking names on Xbox live, or spending time with his family and fiancée.

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