Sr. Quality Engineer

Position: Sr. Quality Engineer I
Location: Plainsboro

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Sr. Quality Engineer I will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System. The Sr. Quality Engineer I 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. 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 Sr. Quality Engineer I 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 Sr. Quality Engineer I 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.

Primary responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

* Performs Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined time frames. 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.

* Performs Complaint Investigations and Failure Analyses.

* 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), Integra Corporation'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.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for this position.

* Education:

Bachelor's Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.

* Experience:

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, Track Wise, and statistical software.

* Must be able to work independently with minimal supervision.

Salary Pay Range:

$1.00 - $ USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined…