Consultant, Medical Device, Supplier Quality Engineer

About

Our client, a growing medical device company, has engaged GForce Life Sciences, to identify a Supplier Quality Engineer to assist with ongoing baseline business.

Duties / Expectations of Role

• The Supplier Quality Engineer should be familiar with quality functions, process flows, control plans, build instructions, process verification and validations (IQ/OQ/PQ), and quality inspection.
• Manager Supplier Change requests and initiate Supplier Change Control Processes
• Track CRF Responses
• Validating document testing, process flow and document regulations
• Work on supplier quality contracts
• Prepare draft Quality and Technical Agreements for existing and new suppliers
• Work closely with other HCL team working on ECRO process, used to archive the Supplier Quality contract in SAP system.
• Manage Change requests impacting supplier quality contracts
• Assisting with Supplier Selection and Qualification
• Assisting with SCARs, Audits, and Supplier Performance
• Support the Approved Supplier List maintenance/updates
• Ensure suppliers are compliant via objective evidence/documentation gathered over the course of the project using Client supplier qualification process such as SPPA/PPAP.

Mandatory Requirements

• Bachelor of Science in Engineering or an alternative Bachelor’s degree program with certification as a quality engineer (e.g. CQE).
• 3-7+ years of experience in a Quality Engineering role within Medical Device
• Experience working in a Supplier Quality or Continuity environment
• Working understanding of QSR/ISO regulations, design assurance, FMEA, Process Flow, and product testing methods.
• Experience in process validations: creating, reviewing, and approving protocols and reports, and execution of protocols.
• Experience with PPAP and Gage R&R
• Experience to include all components of production and process controls including, IQ, OQ, PQ, PPQ, manufacturing equipment software (CSV), and TMV/MSA.

Term & Start

• 3+ months contract
• Start in April
• Onsite/Hybrid in NJ preferred
• Benefits included (Medical, Dental, Vision, 401k)