Quality Engineer II

Peak Performers has partnered with a medical device company to assist in their search for an onsite Quality Engineer II in Plainsboro, NJ. In this position, you will be responsible for providing quality compliance support on all aspects of the quality system. 

Major duties

• Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes. Ensures investigations and root cause analysis are accurate and complete.
• Maintain an accurate log of Non-Conformances and CAPAs activities. Tracks, follows-up and assists in the timely closure of NCs/CAPAs.
• Provides hands-on guidance and training to all personnel performing activities within the Quality system.
• Ensure documentation is complete before closure.
• Assist Quality Systems team as needed to investigate Non-conformances and ensure proper implementation of CAPAs.
• Prepare monthly and quarterly metrics to present at Quality Review meetings.
• Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), company policies and procedures, and other applicable regulatory agency requirements.
• Interact and coordinate activities with other departments, external vendors and customers.
• Perform other Quality Systems related duties as required.

What are we looking for?

• Bachelor’s Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.
• 3 to 5+ years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
• Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.
• Demonstrates excellent organizational and communication skills.
• Proficient with the MS Office Suite, and statistical software.
• Must be able to work independently with minimal supervision

Exciting Opportunity Details

• Rate: $48.63/hour

• W2 Contract

• Worksite Location: Plainsboro, NJ 08536

• Onsite (must reside in the state of New Jersey)

• 6 month contract

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days

• Our employees may choose to participate in a 403(b) retirement plan

• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement

• We pay weekly through direct deposit

• In business since 1994 and thousands of job placements

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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