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.

About the role

In this position, you will be responsible for providing quality compliance support on all aspects of the quality system.

Responsibilities

• Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
• Ensures investigations and root cause analysis are accurate and complete.
• Maintains 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.
• Ensures documentation is complete before closure.
• Assists Quality Systems team as needed to investigate Non-conformances and ensure proper implementation of CAPAs.
• Prepares 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.
• Interacts and coordinates activities with other departments, external vendors, and customers.
• Performs other Quality Systems related duties as required.

Requirements

• 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.

Pay

$48.63/hour (W2 contract)

Schedule

• 6-month contract
• Onsite in Plainsboro, NJ 08536

Benefits

• Excellent medical, dental, and vision insurance available after 60 days.
• Option to participate in a 403(b) retirement plan.
• Priority placement for qualified applicants with chronic medical conditions and/or disabilities.
• Weekly pay through direct deposit.

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. Work authorization that does not require sponsorship for a visa now or in the future is required.