Advanced Quality Engineer
About The Position
The Advanced Quality Engineer has principal responsibility for managing highly complex projects involving the STERIS Quality Management System, service or manufacturing process quality improvements, and technical product or service quality improvement. The work requires significant cross-functional participation and support from all levels of STERIS. The role leads acquisition or new-site quality system integration; production and process control integration; quality measurement system implementation; business-wide quality system standardization; and technical analysis and improvement of product, service, and manufacturing quality. The role may also lead and execute quality strategy for multiple manufacturing or service production lines. It manages processes and leads projects to maintain and improve the quality system in accordance with applicable standards and regulations, including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR. The position is based onsite at the Mentor, Ohio facility, Monday through Friday, and may require travel up to 10% for training or visits to suppliers and other STERIS sites domestically and internationally, including Mexico.
Requirements
- Bachelor's degree in Engineering.
- At least 8 years of related experience in manufacturing/quality engineering and/or quality systems.
- At least 8 years of experience working in an ISO-certified environment.
- Experience with medical device or other regulated industries.
- QMSR certification or familiarity with QMSR/GMP regulations.
- Ability to travel up to 10% for training or visits to suppliers and other STERIS sites domestically and internationally, including Mexico.
Nice To Haves
- ASQ certification.
- Project management skills and experience.
- Experience with design transfer, process harmonization, and sustainability.
- Knowledge of TrackWise, Windchill PLM, or similar systems.
- Knowledge of ISO 13485 regulations.
Responsibilities
- Lead QMS integration for acquisitions and new manufacturing or service sites.
- Lead production and process control integration and improvement for acquisitions and new manufacturing or service sites.
- Lead Quality Management System design, implementation, and improvement for new and existing manufacturing and service sites.
- Design and implement quality measurement systems and improvements for new and existing manufacturing and service sites.
- Analyze data and trends to ensure the acceptance and effectiveness of site quality measurement systems.
- Lead business-wide Quality Management System standardization initiatives.
- Lead key manufacturing and service quality improvement initiatives and strategies.
- Lead and execute quality strategy for multiple manufacturing or service production lines.
- Develop, implement, maintain, and improve complex quality programs, including product and service quality, supplier controls, and production and process controls.
- Develop and generate reports and analyses on quality improvement initiatives for presentation to senior management.
- Provide input to the annual Quality Planning Process.
- Instruct STERIS employees in quality principles, including quality systems, problem solving, and valid statistical techniques.
- Direct Quality and other cross-functional staff in executing key projects and initiatives.
- Share technical knowledge with team members, identify technical problems, and provide innovative solutions.
- Generate alternatives and take reasonable risks when solving technical problems.
- Prepare detailed, high-quality technical documentation to capture and communicate designs.
- Complete tasks on time with minimal supervision while identifying potential risks.
- Drive process improvements for better efficiency 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.
- Pet insurance and other add-on benefits or discounts.
- 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
Senior
