Quality Engineer II
About The Position
The Quality Engineer II is responsible for maintaining and improving STERIS quality systems in accordance with applicable standards and regulations, including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Parts 820 and 211, and EU MDR. The role supports complaint and CAPA investigations, supplier quality improvement, production and process controls, and product and service quality improvement using statistical techniques and accepted quality principles. It executes activities related to the development, implementation, maintenance, and continuous improvement of quality systems. This position is onsite at STERIS's Eden Prairie, Minnesota facility, Monday through Friday during core business hours of either 7 a.m. to 4 p.m. or 8 a.m. to 5 p.m. Occasional early-morning calls with the team in Germany are required, and travel to local supplier sites may be up to 10%.
Requirements
- Bachelor's degree in Engineering.
- At least 3 years of related experience in Manufacturing/Quality Engineering and/or Quality Systems.
- At least 3 years of experience working in an ISO-certified environment.
- Experience in medical device or other regulated industries.
- Ability to travel to local supplier sites up to 10%.
Nice To Haves
- ASQ certification.
- QMSR certification or familiarity with QMSR/GMP regulations.
- Knowledge of TrackWise, Windchill PLM, Grand Avenue, or similar systems.
- Experience with supplier controls, supplier audits, or supplier monitoring.
- Knowledge of ISO 13485 regulations.
Responsibilities
- Participate on cross-functional new product development teams, focusing on product and service quality and Quality System compliance.
- Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC, and trend analysis.
- Initiate or participate in process and product corrective actions and problem-solving activities.
- Update or establish documented work instructions as needed.
- Review collected data, perform statistical analysis, and recommend process or product changes to improve quality.
- Monitor and report on performance metrics.
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and facilities on quality-related issues.
- Support evaluation and disposition of nonconforming materials to maintain product integrity and quality.
- Perform quality system audits and provide guidance on corrective actions.
- Share technical knowledge, identify technical problems, and provide innovative solutions.
- Generate detailed, high-quality technical documentation to capture and communicate designs.
- Complete tasks on time with minimal supervision while identifying potential risks.
- Drive process improvements and use advanced tools and best practices to track product and process metrics.
- Mentor team members on timely task completion and participate in brainstorming sessions.
- Perform other duties as assigned.
Benefits
- Market-competitive pay and eligibility for bonus participation.
- Extensive paid time off and additional holidays.
- Healthcare, dental, and vision benefits.
- Long- and short-term disability coverage.
- 401(k) with company match.
- Maternity and paternity leave.
- Additional benefits and discounts, such as pet insurance.
- Tuition reimbursement and continuing education programs.
- Opportunities for advancement in a stable, long-term career.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
