Supplier Quality Engineer

The Supplier Quality Engineer in our St. Louis, MO location 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. You will lead 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. In this role you will plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Day Shift: Monday to Thursday (four 10-hour day schedule) with most Fridays off!

• Serveas the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.
• Developand implementstatistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.
• Leadprocess and product corrective actions and problem-solving activities.
• Reviewthe current quality system and recommend / implement improvements as needed.
• Usedata to perform statistical analysis and recommend process / product changes to improve product and service quality.
• Leadprojects focused on quality system, product quality and service quality improvements.
• Developanalyses and reports on the performance of the quality system.
• Leadsupplier audits and corrective actions.

• Leadand supportinternal and external quality system audits.
• Instructother STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaboratewith other departments and facilities within the company on quality related issues.
• Maintainproduct integrity and quality through the evaluation and disposition of nonconforming materials and processes.

Required:

• Bachelors' degree in Engineering or related technical field.
• Minimum 6 years' combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum 6 years' 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.
• Experience with MS Office applications including Excel, Word, and PowerPoint.

Preferred:

• Minimum 6 years' experience with medical device or other regulated industries preferred.
• ASQ- Certified Quality Auditor and/or Quality Engineer, QSR or familiarity with QSR/GMP regulations preferred.
• Experience with statistical analysis software and Visio preferred.
• Experience with Supplier Quality or Supplier Management, preferred.
• Experience with electronic Quality Management Systems (QMS), preferred.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• 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

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