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Position:  Medical Quality Assurance Technician
Location:  Lewis Center, OH
Job Id:  360
# of Openings:  1

Medical Quality Assurance Technician
Abrasive Technology is a world-leading innovator in the development and manufacture of superabrasive grinding wheels and tools with locations around the globe. Our products shape the world around us every day – providing grinding, cutting, drilling and polishing solutions for a wide variety of industrial materials.
 
We collaborate with leading aerospace companies, Silicon Valley OEMs, medical device makers, and automotive manufacturers to solve their toughest application needs and improve their bottom-line.
 
We recognize change is constant and encourage our people to search for better solutions. In fact, the associates of Abrasive Technology are responsible for some of the industry’s most dynamic innovations over the past 40 years, including the revolutionary P.B.S. braze.
 
The Abrasive Technology culture strongly promotes work/life balance. We maintain a worldwide manufacturing presence, as well as a system promoting agility and nimbleness. And our flat, collaborative structure provides unbridled opportunity for career and personal growth.
 
If you’re driven by opportunity and seek a different way of thinking, we’d love to talk about how you may fit into our environment. Abrasive Technology currently has an opening for an energetic professional to join our Quality Assurance team. The position is located at our world headquarters in Lewis Center, off of Polaris Parkway and will support our multiple plant locations.
 
Essential Duties and Responsibilities of the position include:
  • Ensure compliance with Quality standards/certifications and customer’s Quality system requirements
  • Implement compliance initiatives with medical device regulations, register/renew products with governing bodies, and maintain technical files
  • Understand requirements for applicable standards (e.g. ISO13485 MDD and MDSAP, ISO9001), prepare/plan/host 2nd and 3rd party audits, and implement corrective actions
  • Maintain document control process by processing document revisions and ensuring proper notification/training is completed
  • Prepare internal audit program and execute accordingly
  • Facilitate root cause and corrective action initiatives
Qualified candidates will possess the following experience:
  • A Bachelor’s degree in relevant or related technical field
  • 1-3 years of experience as a Quality Assurance professional in the medical device industry preferred
  • Preferred Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485:2003/2016
  • Experience participating in internal and external audits preferred (e.g., FDA, Notified Body, Supplier)
  • Experience with CAPA, complaint investigation, field action processes and risk management
  • Prefer quality related certifications (e.g. ASQ)
  • Machining, electroplating, brazing experience a plus
  • Demonstrated collaborative group problem solving with ability to work independently
  • Ability to manage and document multiple projects on a continuous basis
  • Excellent communication skills with demonstrated ability to write work instructions and effectively train associates
  • Ability to read part prints and drawings
In addition to great starting wages, Abrasive Technology also offers our associates:
•    Medical, dental and vision
•    Fully company-paid profit-sharing retirement plan
•    Quarterly incentive bonuses
•    Tuition reimbursement
•    Vacation and Sick/Personal Time, and
•    PAID Plant Shutdown in December

Abrasive Technology is an Equal Opportunity/Affirmative Action Employer. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

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