Quality Engineer- QMS IV

Quality Engineer- QMS IV
  • Competitive
  • Temporary
  • Neenah WI, US Neenah WINNEBAGO US 54956
Job Ref: JO000115092
Sector: Clinical
Sub-sector: Quality
Date Added: 05 April 2021

Quality Engineer IV

Renewable Contract - Neenah, WI

Candidate must have FDA medical device Class 2 or Class 3 Risk Management and Design engineering experience. This is a Quality Engineer role supporting Risk Management File documentation updates (FMEAs, Risk Management Plans, Risk Assessments, and associated procedures), change control creation and execution in a document and change management system (EtQ). Primary responsibilities will include the writing and updating of Quality procedures and work instructions governing the Risk Management and Design activities. This will require learning our change control process, opening and managing change package through to release. This individual will also work with engineering teams to execute the Risk Management and Design activities to create Risk Management File deliverables. The candidate must have experience working in Design Controls and Change Control systems for FDA regulated medical devices. The role will be supporting Quality system improvement initiatives – remediation of quality system documentation, design documentation, DHFs, DTMs, RTMs, etc. We need a team member with strong technical skills, excellent written English and oral communication skills and high attention to detail. Experience in ETQ as a quality system is preferred


• Excellent written and oral English language skills

• Quality system documentation and change management experience

• Medical device (FDA Class II) Risk Management engineering development project support

• QMR presentation slide preparation

• CAPA Investigation and Effectiveness support

• Procedure, Work Instruction and quality system documentation

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

19/04/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Ryan Heavirland

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