Supplier Quality Engineer

GForce Life Sciences; United States; Hybrid; USD 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Medical Insurance

Dental Insurance

Vision Insurance

401k Plan

Zusammenfassung

A growing medical device company is seeking a Supplier Quality Engineer to assist with baseline business. This role involves managing Supplier Change requests, documenting quality processes, and ensuring supplier compliance to standards. Candidates should have a Bachelor’s degree in Engineering and 3-7+ years of Quality Engineering experience, preferably in the medical device industry. The position is a contract role, starting in April, with both onsite and hybrid options available in New Jersey. Benefits include medical, dental, vision, and 401k.

Qualifikationen

• 3-7+ years of experience in a Quality Engineering role within Medical Device.
• Working understanding of QSR/ISO regulations and product testing methods.
• Experience in process validations, creating and executing protocols.

Aufgaben

• Familiar with quality functions, process flows, control plans, and inspections.
• Manage Supplier Change requests and initiate Control Processes.
• Prepare draft Quality and Technical Agreements for suppliers.

Kenntnisse

Quality Engineering

Supplier Quality Management

Process Validation

QSR/ISO Regulations

FMEA

Ausbildung

Bachelor of Science in Engineering or Quality Engineer Certification

Tools

SAP

PPAP

Jobbeschreibung

Consultant, Medical Device, Supplier Quality Engineer

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

Summary

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 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.

Term & Start

• 3+ months contract
• Start in April
• Onsite/Hybrid in NJ preferred - one day/week in the office
• Benefits included (Medical, Dental, Vision, 401k)