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.
Go to our website to apply https://prentkeromich.bamboohr.com/careers
Duties and 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.
Education and Experience
- 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.
Required Skills/Abilities
- 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.
