Quality Assurance Engineer II

Position Title: Quality Assurance Engineer II
Work Location: Plainsboro, NJ 08536
Assignment Duration: 9+ Months
Work Arrangement: Onsite
 
Note:

• This is Temporary to Permanent Hire
• NC/CAPA experience required, Complaint experience is a bonus.
• Trackwise digital exp is not required
• Med device experience preferred/Pharma - Regulated Industry

 
Position Summary:

• The Quality Assurance Engineer II will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System.
• The Quality Assurance Engineer II will monitor, prioritize and track the timely closure of NCs and CAPAs for the Plainsboro Plant facility, participate in problem solving teams, and participate from a Quality Engineering & Quality Systems and Plant perspective on the launching of new or improved products/processes.
• He or She will act as a Quality Reviewer for NCs and CAPAs, in addition to being responsible for the quality efforts in other areas of the NC/CAPA system, including Complaints.

 
Background & Context:

• Monitor, prioritize and track the timely closure of NCs, CAPAs and Complaints for the Plainsboro Plant facility.
• Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
• The QA Engineer II will collaborate with site NC investigators and CAPA owners from cross-functional areas to facilitate timely and effective closure of all Quality System records.
• The QA Engineer II will provide guidance to both technical and non-technical cross functional resources on how to conduct effective investigations and corrective actions, and will troubleshoot, escalate, and aid in resolving all product and/or process quality issues.

 
Key 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.
• 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 Nonconformances 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), our organization's 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.

 
Qualification & Experience:

• Education: Bachelor’s Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.
• Experience: 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $42.00/hr - $45.58/hr.