Quality Engineer

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

Why You’ll Love Working Here

* Mission-Driven Work: Help ensure the quality and reliability of technology that positively impacts lives.
* Meaningful Impact: Play a key role in product quality, regulatory compliance, and continuous improvement.
* Collaborative Environment: Partner with engineering, manufacturing, procurement, and regulatory teams.
* Professional Growth: Expand your expertise in medical device quality systems, design controls, and regulatory requirements.

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.