Lead Quality Assurance Engineer-medical device
George Konik Associates - Minneapolis, MN

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The Lead Quality Assurance Engineer is responsible for the management and compliance of the Quality Assurance function for the company, including:

v Supervision of Quality Assurance Associates.
v Complaint System Management.
v Corrective Action Report/Preventative Action Report System Management.
v Managing the Material Review Board (MRB).
v Overseeing the equipment calibration program.
v Developing new product inspection and testing procedures.
v Developing improved inspection and test methods.
v Managing the sterilization process.
v Keeping the controlled environment areas conforming to required standards.

  • Meet with the Quality Manager on a regular basis to review and analyze quality data such as complaints, scrap, defect trends and overall compliance to the Quality System.
  • Work closely with the Quality Manager to review to address remarks from internal and external audits.
  • Schedule, plan and coordinate/host all regulatory and customer audits under the direction of the Quality Manager and Vice President of Engineering.
  • Work with the Leadership Team to represent and contribute information on behalf of the Quality Assurance Team.
  • Ensure all Quality Assurance Associates are properly trained for existing and new products.
  • Review and organize complaint system.
  • Coordinate complaint flow and tracking of trends.
  • Organize and manage the Corrective Action /Preventative Action report system.
  • Monitor Material Review Board activities and coordinate dispositions.
  • Maintain up-to-date calibration for all required measuring equipment and ensure all corresponding documentation is organized and up to date.
  • Develop new or improved inspection and test methods to assure maximum quality assurance at the lowest practical cost. Train and certify inspectors.
  • Evaluate new customer and product quotes from a Quality Assurance standpoint to assure all requirements are defined as required by QSP-028.
  • Work with Manufacturing and Engineering in validation plan generation, execution and approval for all process validation as required by QSP-028.
  • Maintain a continual awareness of the cost and effectiveness of all receiving, 1 st article, in-process and final inspections.
  • Correlate in-process material defects to receiving inspection effectiveness and upgrade methods, materials or suppliers accordingly.
  • Work with Production on the integration of assembler self-inspection and accountability into the overall quality system.
  • Initiate customer requested sterilization validation procedures (SVP).
  • Assure proper labeling, load size and control over all loads to sterilizers.
  • Verify sterility of all loads coming back from sterilizer.
  • Assure appropriate paperwork is provided to customers prior to final product release.

  • Bachelor’s Degree in Engineering or Technical Degree in an engineering discipline.
  • A minimum of 5 years supervising quality assurance in a medical manufacturing environment.
  • Thorough working knowledge of cGMP, FDA QSR and ISO 13485 standards.
  • Excellent overall understanding of Quality Assurance and Quality Control practices and procedures.
  • Experience in cellular manufacturing ( Lean, One-piece flow) preferred.
  • Ability to produce highly accurate work, and prioritize responsibilities for multiple projects with strict deadlines.
  • Excellent record/documentation management skills.
  • Intermediate to advanced skills with Microsoft Office; experience in SPC.
  • Excellent verbal and written technical communication skills.
  • Ability to work professionally with customers and cross-functionally with internal teams.
Haley Behrens



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