Quality Assurance Engineer - Medical

Abrasive Technology, Ltd.; Lewis Center (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Company paid life insurance

Disability insurance

401k with company match

Quarterly incentive bonuses

Flexible hours

Paid time off

December plant shutdown

Job summary

Abrasive Technology is seeking a Quality Engineer to join our Medical Products team and help assure the delivery of high-quality medical devices used in critical applications worldwide.

You will collaborate across engineering, manufacturing, and operations to drive continuous improvement, perform root cause analysis, and support regulatory compliance. This role emphasizes cross-functional teamwork and a strong commitment to ethics and quality.

Qualifications

• Five+ years of quality engineering experience.
• Experience applying quality requirements in medical device environments.
• Experience with ISO 9001/13485, regulatory standards preferred.

Responsibilities

• Ensure compliance with ISO 9001, ISO 14971, ISO 13485 and MDSAP.
• Improve Cost of Quality for the medical business segment.
• Serve as the primary medical product quality contact for external customers.
• Ensure quality/design requirements are met on time.
• Lead root cause analysis and corrective action teams.
• Develop and execute internal audits for customer standards.
• Perform full Quality Engineering functions including supporting manufacturing.
• Recommend and implement quality improvements and new systems.

Skills

Quality engineering experience

Regulatory compliance

Project management

Ethical conduct

Analytical thinking

Education

BS in Engineering/Engineering Technology

Job description

Shape Quality Excellence in Medical Manufacturing

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

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.
• Demonstrated ability to work in a team, self-motivated and adaptable to multiple challenges.

Required Qualifications:

• BS Degree in Engineering/Engineering Technology or equivalent experience
• Minimum of 5 years Quality Engineering experience
• Experience in medical product and/or medical device market a plus.
• 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 escalat[e] issues in the face of competing company priorities.

Desired Qualifications:

• Experience in the dental bur industry
• Experience using Lean Manufacturing and Kaizen techniques.
• Must show exemplary diplomacy with customers.

About Abrasive Technology

Abrasive Technology’s medical products demonstrate our industry leading commitment to precision manufacturing and are preferred around the world. From intravascular applications to cleaning and cutting where precision matters, our tools are engineered for superior craftsmanship for various medical applications. The medical tool market continues to expand globally, and Abrasive Technology expects to have many new and exciting growth projects well into the future.

In addition to great starting wages, Abrasive Technology also offers our associates:

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

Access to our facility (and, therefore, employment) is restricted under the International Traffic in Arms Regulations (ITAR) and/or Export Administration Regulations (EAR) to U.S. Citizens, lawful permanent residents of the United States and properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes.

Abrasive Technology is a substance and drug free workplace. All offers of employment are contingent on successfully passing a pre-employment drug screening and criminal background check.

For aerospace-related positions, drug testing is conducted in accordance with the Federal Aviation Administration (FAA) and Department of Transportation (DOT) guidelines. These guidelines require testing for the presence of marijuana, cocaine, opiates, phencyclidine (PCP), and amphetamines.

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

We prefer to speak directly with candidates who are interested in joining our team. Recruiters and staffing agencies, please do not reach out regarding this role.