About the position
The Senior Product Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. This role requires onsite work in our Plymouth, Minnesota location with up to 10% domestic travel to other STERIS locations or to visit supplier sites as required.
Responsibilities
- Serve as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
- Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
- Lead process and product corrective actions and problem-solving activities.
- Review the current quality system and recommend / implement improvements as needed.
- Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.
- Lead projects focused on quality system, product quality and service quality improvements.
- Develop analyses and reports on the performance of the quality system.
- Lead supplier audits and corrective actions.
- Lead and support internal and external quality system audits.
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with other departments and facilities within the company on quality related issues.
- Supervise Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
- Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
Requirements
- Bachelor's degree in Engineering or related technical field.
- Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- Minimum of 6 years of experience working in an ISO certified environment required.
- Excellent problem-solving skills.
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on own initiative.
- Demonstrated excellent organizational, oral and written communications skills.
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
- Ability to travel domestically up to 10 % to STERIS locations or to visit supplier sites as required.
Nice-to-haves
- Experience working as a Product Quality Engineer in a regulated industry.
- Experience with statistical analysis software and Visio.
- Minimum of 6 years of experience with medical device or other regulated industries.
- ASQ, QSR or familiarity with QSR/GMP regulations.
Benefits
- Market Competitive pay
- Extensive Paid Time Off and added Holidays
- Excellent Healthcare, Dental and Vision benefits
- Long- and Short-Term Disability coverage
- 401(k) with a company match
- Maternity and Paternity Leave
- Additional add-on benefits / discounts for programs such as Pet Insurance
- Tuition Reimbursement and continuing education programs
- Excellent opportunities for advancement in a stable long-term career
