Senior Quality Engineer

Reference Number: 476
Location: NJ

Senior Quality Engineer

Our client is in the Medical Device space, involved in a variety of products but focused on products that are adaptable between surgical procedures.  We are working with them to find the kind of Sr. QE that enjoys being out there on the floor with the “folks” because they are driven to improve the condition; making it better for the people doing the work and the company they work for; but most importantly making it safer for the patient.  You need to know ISO 13485 and 14971 but more importantly you have to know how to make them important to your management, peers and subordinates. 

Have you read the “but” yet?  Here it is, not only is this position not for the “highfalutin” engineer unwilling to engage from the shop to the management level, it’s located in a fairly rural area.  What that means to you is if your limits include an unwillingness to be in the country this isn’t the job for you.  Still interested? 

RESPONSIBILITIES –

  1. In-depth knowledge of Process Capability and Process Control supporting cross-functional efforts from NPD to Transfer and including legacy products, implementing Lean ‘type’ initiatives
  2. Active participant in CAPA from identification to implementation to resolution including improvement of the system, timely responses and training
  3. Understands the interaction of Maintenance and Risk and how to define strategies that reduce Complaints
  4. Mentors peers, subordinates, shop-floor and entry level personnel on an effective QS
  5. Defines/implements DOE’s/Protocols with NPD and Manufacturing for DFM/DFA
  6. In depth understanding of how to effectively implement and document IQ/OQ/PQ
  7. Works with NPD to ensure effective V&V
  8. Identifies opportunities for systems improvements and may participate in their implementation
    1. Cross-functional Quality duties include support of disciplines, practices and auditing; representing Quality on Core Teams

REQUIREMENTS –

  • BS in Engineering or other appropriate technical discipline
  • >5 years’ experience as a QE in a med device regulated role
  • ISO 13484 & 14971 experience required including know-how with 21CFR
  • Demonstrable skills with Quality Tools/methodologies
  • Foundational skills with the Microsoft Office Suite, Project and some CAD experience
  • Must be able to exemplify Project and Cross-Functional skills, demonstrating mutually satisfying resolution to Quality challenges
  • Pluses include ASQ CQA/CQE, PMP or advanced technical degree
  • Must be able to communicate fluently in English, both verbally and in a written form
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