Quality Assurance Engineer - Medical

Abrasive Technology Inc; Lewis Center (OH); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Company paid life insurance

Short-term disability

Long-term disability

401k with company match

Quarterly incentive bonuses

Flexible hours

Paid time off

Plant shutdown in December

Job summary

Abrasive Technology in Lewis Center, OH is seeking a Quality Assurance Engineer for Medical products. The role focuses on ensuring stringent quality across engineering, manufacturing, and operations, driving continuous improvement and regulatory compliance to support critical medical applications worldwide.

You will lead audits, root-cause investigations, and cross-functional quality initiatives, working in a fast-paced manufacturing environment to deliver high-quality medical tools and devices.

Qualifications

• BS Degree in Engineering/Engineering Technology or equivalent experience.
• Minimum of 5 years Quality Engineering experience.
• Experience in medical product/manufacturing environment and regulatory requirements.
• Experience applying quality requirements to medical devices.

Responsibilities

• Ensure compliance with ISO 9001, ISO 14971, ISO 13485 and MDSAP across the department.
• Manage and improve Cost of Quality for the medical segment.
• Serve as primary medical product customer quality assurance contact for external customers.
• Ensure quality and design requirements are executed on time.
• Lead root cause analysis and corrective action for quality issues.
• Develop and execute internal auditing processes for ongoing compliance.
• Support manufacturing, training, material certification review, and root cause analysis.

Skills

Quality Engineering

Project management

Regulatory compliance

Root cause analysis

Medical device familiarity

Education

BS Degree in Engineering/Engineering Technology

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Quality Assurance Engineer - Medical

Full Time Tech Professional Lewis Center, OH, US

3 days ago Requisition ID: 1134

Salary Range: $90,000.00 To $110,000.00 Annually

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 escalate 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.