Senior Quality Engineer

Marietta, Georgia | Quality Assurance / Safety

Sr. Quality Engineer

 

Our client is a Medical Device manufacturer and as described by the manager “There is a lot of enthusiasm for what we do here; it’s a truly great place to work!” This is a hands-on role where on any given day you’ll be active on the production floor, interacting with project teams, and with operators/assemblers to ensure the client’s production demands are met. You will also be coaching/mentoring/leading more junior QE’s, providing SME type guidance on Quality Tools and Lean/SS.

 

Yes, you will manage projects and interact beyond the silo as well as be challenged across the breadth of the demands of the QS and expected to navigate the challenge. Your experience in an assembly/manufacturing environment is critical, as is your problem-solving. You’ll be heavily involved with Root Cause and defining sustainable CAPA’s; using those results to build a ‘storyboard’ to communicate to the management group. The environment has manual processes that present the opportunity for Improvement and your LEAN skills will help identify tangible cost savings.

 

RESPONSIBILITIES:

  • Owns all product quality issues whether defect or risk related
  • Is an SME to other Quality personnel providing guidance and instruction
  • Monitors, analyzes, interprets, and presents results of data collected from FPY, SPC, and PPM
  • Writes/reviews Work Instructions, procedures, alerts, control plans and protocols
  • Ensures Manufacturing compliance to internal and external requirements; responding to data, audit, and validation results
  • Works with manufacturing to identify improvement opportunities through new technologies, tools and systems; guiding the validation process (IQ/OQ/PQ) to ensure effective implementation
  • Leads, or participates in improvement projects, e.g. Kaizen and CAPA
  • Assists other departments in the evaluation and ultimate qualification of new suppliers
  • Assists in the Supplier Audit process including travel for onsite problem-solving
  • Investigates, for improvement opportunities, supplier quality & delivery issues
  • Involved with writing, managing and implementing Work Instructions, PFMECA’s, and Quality Plans

REQUIREMENTS:

  1. Technical degree, e.g. BSME, with 5 years of hands-on experience in Manufacturing Quality
  2. Prefer Quality Certifications from ASQ, (e.g. CQE, CQA, CSQP)
  3. Software experience including CAD (SolidWorks or AutoCAD), data acquisition & utilization (Tableau or Power BI), MasterControl or other EQMS
  4. Proficiency in the use of the MS Office Suite
  5. Well-developed knowledge of statistical analysis and Six Sigma techniques, proficiency with Minitab
  6. Evident problem-solving skills
  7. Experience with Quality Systems like ISO 9001 or AS9100, ISO 13485, prefer experience in an FDA or regulated environment
  8. Strong sense of the importance of accurate Documentation & Reporting; experience approving/reviewing process qualifications like IQ/OQ/PQ, PPAP and/or First Article
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