Quality Assurance Engineer - Medical

Abrasive Technology Inc•Orange Township, OH
•$90,000 - $110,000•Onsite

About The Position

At Abrasive Technology, quality is at the core of everything we do. We are seeking a Quality Engineer to join our Medical Products team and help ensure the delivery of innovative, high-quality products used in critical medical applications around the world. In this role, you'll collaborate across engineering, manufacturing, and operations to drive continuous improvement, solve complex quality challenges, support regulatory compliance, and make a direct impact on product performance and customer satisfaction. If you're passionate about quality, enjoy working in a fast-paced manufacturing environment, and want to be part of a growing business with meaningful work, we'd love to hear from you.

Requirements

  • BS Degree in Engineering/Engineering Technology or equivalent experience
  • Minimum of 5 years Quality Engineering experience
  • Experience with applying quality requirements, regulations, processes, and procedures in medical device manufacturing environment.
  • Ability to prioritize and manage multiple critical projects simultaneously.
  • Strong ethics to escalate issues in the face of competing company priorities.

Nice To Haves

  • Experience in the dental bur industry
  • Experience using Lean Manufacturing and Kaizen techniques.
  • Must show exemplary diplomacy with customers.
  • Experience in medical product and/or medical device market a plus.

Responsibilities

  • Ensure departmental compliance with requirements of internationally recognized quality management systems including ISO 9001, ISO 14971, ISO 13485 and MDSAP
  • Manage and improve Cost of Quality to the company for the medical business segment.
  • Be the primary medical product customer quality assurance point of contact for external customers.
  • Ensure that all quality and design requirements are executed on time.
  • Lead root cause analysis and corrective action team in resolving quality issues.
  • Develop and execute internal auditing processes to ensure ongoing compliance of customer standards.
  • Perform all Quality Engineering functions, i.e., mfg. support, training, raw material certification review, root cause analysis, etc.
  • Recommend and implement improvements to quality department including improved technology, systems improvements, procedural updates, etc.

Benefits

  • Medical, dental, and vision insurance
  • Company paid life insurance, short-term disability, and long-term disability
  • Company matched 401k plan
  • Quarterly incentive bonuses
  • Tuition reimbursement
  • Flexible hours
  • Paid time off
  • PAID plant shutdown in December
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