At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
The position is responsible for developing, maintaining and improving 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.
This role would support complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement 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.
Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
Initiate and/or participate in process and product corrective actions and problem-solving activities.
Update/establish documented procedures as needed.
Review collected data to perform statistical analysis and recommend process/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 within the company on quality related issues.
Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
Perform quality system audits and provide guidance on corrective actions.
Perform all other duties as assigned.
- Manufacturing / Quality Engineering and/or Quality Systems experience.
- Experience in medical device or other regulated industry preferred.
- Experience working in an ISO certified environment required.
- Familiarity with QSR/GMP regulations preferred.
- Excellent problem-solving skills.
- Experience working on cross-functional teams.
- Demonstrated excellent organizational, oral and written communications skills.
- Must be flexible in working overtime as necessary.
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, PowerPoint.
- Experience with statistical analysis software preferred.