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QUALITY ASSURANCE MANAGER-MEDICAL DEVICES

CAROL STREAM, IL
Responsible for the general management of the Manufacturing Quality Assurance function to ensure compliance to established standards of corporate objectives and regulated agencies for industry (ISO and FDA). Responsible for the planning, development and implementation of quality systems that support the BBI Manufacturing site objectives and resources.

Responsibilities:

  • Serve as Quality Manager for all operations activities.
  • Supervise the Quality Inspection, QC Shipping/Receiving and Calibration Departments.
  • Supervise operations quality engineers.
  • Coordinate inspection activities to insure product and process compliance to acceptance requirements.
  • Control nonconforming product and coordinates final product acceptance/release activities.
  • Oversee operations quality involvement in process validation activities.
  • Develop, implement, and maintain quality systems to ensure FDA and ISO compliance.
  • Assist and/or lead the migration of the BBI quality system from on division to another.
  • Optimize quality systems to effectively identify, measure and reduce cost of quality activities.
  • Identify, support, and develop departmental resources to achieve business and quality objectives.
  • Actively participate in all facility audits (FDA, ISO, Corporate and Division).
  • Participate in the development of process FMEAs.
  • Review and approve all engineering changes for existing product, processes, and materials.
  • Promote and support multi-discipline teamwork.
  • Oversee establishment of manufacturing quality plans for transferring product designs to manufacturing.
  • Maintain calibration system and associated activities.
  • Manage the Material Review Board process.
  • Support existing product/process improvement programs.
  • Support new product development programs.
  • Hire and develop Quality resources at BBI.

 

Required Qualifications:

  • Process validation experience, including packaging and labeling processes.
  • Technical knowledge of measuring equipment and the required calibrations.
  • Strong working knowledge of QSR, ISO 13485, MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.
  • Experience conducting quality audits (internal and supplier).
  • Experience managing and hosting external audits (e.g. FDA, ISO).
  • Strong organizational skills.
  • Strong working knowledge of statistical quality tools.
  • Strong oral and written communication skills.

 

Preferred Qualifications:

  • ASQ Certification (CQE, CRE, CQA, CQM) preferred.

 

Education and/or Experience:

  • Minimum of a four-year degree in an Engineering discipline. Mechanical or Biomedical Engineering degree preferred.
  • Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.
  • Minimum 5 years supervisory experience.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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