Quality Manager

Illinois | Quality Assurance / Safety

Quality Assurance Manager

 

Our client is a successful, multi-national Contract Manufacturer to Medical Device companies.  They have engaged us to fill this position at one of their premier facilities where machining, secondary operations in passivation & electropolishing, subassembly and assemblies are everyday occurrences.  The qualified candidate will manage a QS compliant to ISO 13485 and 21 CFR 820 and a group of engineers and technicians responsible for its day to day implementation. 

 

As the champion for Assurance; training, auditing, reporting results of Quality KPI’s and generally providing for a culture of Quality will all be in your scope of influence.  Planning, management, coaching and mentoring all need to be innate to your style as they’ll be used on a daily basis.  But the real upside to this position is the organization’s growth and what it can mean for your personal development. 

 

Responsibilities:

  • Manages the Quality Organization to meet goals & objectives, achieve customer expectations, maintain safety, and ensure ethical business practices
  • Provides oversight to and coordinates support for Continuous Improvement, Lean Initiatives, and Process Control
  • Works in partnership with other departments and locations to ensure the consistent application of the QS through Control/Quality Plans, FMEA, V&V, and IQ/OQ/PQ
  • Works with Operations, Executive Quality Management and others to define appropriate, valued metrics and report those across the organizational chart 
  • Ensures the QS provides for the comprehensive implementation of Assurance, meeting the customer’s needs and addressing unforeseen weaknesses with effective, compliant, and timely CAPA
  • Responsible to coordinate, and may perform, qualifications in accordance to divisional processes and in concurrence with the Master Validation Process
  • Provides leadership to their team, promoting autonomy and interdepartmental collaboration
  • Ensures that training programs are in place for general associate training in the QS as well as addressing the needs of new hires
  • Is involved with implementation of enterprise-wide and site Quality objectives
  • Responsible for the documentation system as it applies to the site and corporate systems
  • Is the Management Representative

Requirements:

  1. BS in Engineering or other appropriate science
  2. 8 years’ experience in Quality where at least 3 are as a manager leading a team of 10 or more
  3. In-depth experience with ISO 13485 and knowledge of 21 CFR
  4. Experienced with SPC, the definition of measurements, and how to implement LCL/UCL
  5. Knowledge in GD&T
  6. Experienced in a manufacturing environment, especially around CNC machining
  7. Advanced degree and/or ASQ certifications highly valued
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