Quality Engineer

PRC-Saltillo•Wooster, OH

31d•$60,000 - $75,000

About The Position

This position is where quality, innovation, and continuous improvement come together! The Quality Engineer provides quality support throughout the product lifecycle, including design, development, manufacturing, and ongoing improvement of Class II medical devices and software as a medical device (SaMD). This role partners with cross-functional teams to support quality systems, design controls, risk management, supplier quality, complaint investigations, regulatory compliance, and continuous improvement initiatives.

Requirements

Bachelor’s degree in Engineering, Physical Science, Business, or a related technical field required. Equivalent combinations of education and experience may be considered.
Minimum of 5 years of quality or manufacturing engineering experience in a regulated environment such as medical device, pharmaceutical, biotech, food, aerospace, or automotive industries.
Strong problem-solving, troubleshooting, and decision-making abilities.
Knowledge of quality engineering principles, statistical methods, and continuous improvement tools.
Experience with root cause analysis, FMEA, control charts, DMAIC, PDCA, 5S, and Kaizen methodologies.
Understanding of software and electronic design processes and basic electronic test equipment.
Strong verbal, written, presentation, and facilitation skills.
Ability to work independently and collaboratively in a cross-functional environment.
Strong attention to detail with the ability to analyze complex technical information.
Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
Flexible and adaptable in a fast-paced, changing environment.

Responsibilities

Supports quality systems, regulatory compliance activities, and continuous improvement initiatives.
Develops and maintains quality procedures, work instructions, specifications, and training materials.
Reviews and approves design, product, process, and engineering documentation.
Investigates nonconformances, supplier issues, complaints, and CAPAs using root cause analysis techniques.
Performs testing, validation activities, data analysis, and reporting to support product quality and compliance.
Supports design verification and validation activities and product transfers from engineering to manufacturing.
Develops inspection plans, test methods, and statistical approaches to ensure product and process conformity.
Partners with suppliers and internal teams to improve product quality and manufacturing processes.
Assists with complaint investigations, quality event management, change control, and risk assessment activities.
Participates in audits, regulatory inspections, and quality system improvement efforts.