Quality Engineer

Reference Number: 476
Location: NC

“Be a yardstick of Quality.  Some people aren’t used to an environment where excellence is expected” – Steve Jobs. 

Quality Engineer

Quality is not just a word.  It’s a cultural condition, built upon a foundation of systems that note the importance of performance to the client’s standard, performance to the employer’s standard, functional concern for excellence, profit, and people.  Our client understands that because their clients are in Medical Device.  Their end users are Doctors and their end customers are patients whose lives depend on the products. 

The environment is Contract Manufacturing which means it is fast paced, fast to change and requires the kind of individual who understands flexible to the situation does not mean flexible about the result.  Collaborative, Team Work, Effective Communicator are all words you’ll hear from the hiring authority and their peers every day because they are words that accurately reflect what’s expected of everyone.  We’re looking for a QE with as little as 3 years of experience, who is drawn to collaboration but also understands there are times when “sticking to their guns”, is critical.  You don’t have to have Med Device experience, though it’s welcome, but you have to have demonstrable experience in an environment where Quality’s role is to contribute to the improvement of the condition not to inspect quality into the result. 

RESPONSIBILITIES: 

  1. Participates on teams developing concept to commercialization projects ensuring that production processes and quality objectives are clearly defined prior to transfer, including purchasing & receiving specs, validation criteria, etc.
  2. Writes protocols and/or reviews/approves for verification and inspection (methods and sampling plans) to ensure customer requirements are met and properly documented
  3. Heavily involved in Risk Assessment activities (e.g. PFMEA), championing the importance of understanding risk
  4. Provide supervision to QA Specialists on non-conformance activities ensuring thoroughness, completeness and timeliness are met
  5. Participates in CAPA activities, writing, verifying, and ensuring implementation
  6. Analyzes, summarizes, and reports on KPI’s including trending and system concerns
  7. Participates in and contributes to Continuous Improvement activities as needed
  8. Is the “face” of quality to customers, suppliers, and colleagues
  9. Develops training and training assessment tools as required
  10. Audits internally and externally as required by the QS

REQUIREMENTS: 

  • BS in Engineering or other appropriate science from an accredited university
  • 3 or more years’ experience in a regulated or managed QS environment
  • Excellent communications skills written and verbal
  • Proficient with the MicroSoft Office Suite of software
  • Some experience in interpretation of Regulatory requirements desirable
  • Auditing experience desirable
  • Rudimentary understanding of statistical tools (e.g. SPC) desirable

 

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