GForce Life Sciences | Supplier Quality Engineer | franklin lakes, nj

2 days ago

franklin lakes, United States GForce Life Sciences Full time

Consultant, Medical Device, Supplier Quality Engineer


Summary

Our client, a growing medical device company, has engaged GForce Life Sciences, to identify a strong Supplier Quality Engineer to assist with ongoing baseline business. This role will entail resolving issues by identifying and applying solutions from acquired technical experience and guided precedents. Work effectively & productively with all departments by developing a team atmosphere.


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 Qualitfication
  • 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.


Nice to Have Requirements

  • Certification as a quality engineer (e.g. CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred.
  • Certified Supplier Quality Professional (CSQP).
  • Knowledge of medical manufacturing, specifically related to ISO 13485, is desired.
  • Understanding of Medical Device Regulations (EU) 2017/745,
  • Working knowledge of ISO 13485
  • Working knowledge of 21-CFR-820
  • Working knowledge of FDA Design Controls/ISO13485 and medical device product development
  • Knowledge of blueprint reading and geometric dimensioning and tolerancing
  • Experience in pFMEA, manufacturing process flows, control plans, and quality records are required.
  • Expert knowledge of blueprint reading and geometric dimensioning and tolerancing
  • Knowledge of statistics, manufacturing process control and validation, and process capability
  • Medical device manufacturing experience

Term & Start

  • 6 months+
  • Full-Time (40 hours a week)
  • Possibility of extension
  • Start in December
  • Onsite/Hybrid in NJ preferred
  • Benefits included (Medical, Dental, Vision, 401k)

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