Quality Engineer

The Quality Engineer in our St. Louis, Missouri facility is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. The Quality Engineer supports 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. In this role you will execute activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

This is a day shift position that requires working onsite in our St. Louis, Missouri facility Monday through Friday, with ability to respond to occasional calls after hours or on Saturdays.

• Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
• Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Update/establish documented work instructions 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.

Required:

• BS Engineering.
• Minimum of 1 year of related experience required (combined Manufacturing/Quality Engineering/Quality Systems experience or minimum of 6 months on-site STERIS internship or co-op experience).
• Minimum of 1 year of experience working in an ISO certified environment.

Preferred:

• BS Chemical Engineering, Biochemical Engineering, Biomolecular Engineering.
• Experience with medical device or other regulated industries.
• ASQ Certification, QMSR Certification or familiarity with QMSR/GMP regulations.
• Proficiency with MS Excel including ability to use Pivot Tables to complete data analysis.

Other:

• Analyzes and solves technical problems.
• Seeks input from experienced individuals to improve quality of deliverables.
• Partners with team members to complete assigned tasks on time and seeks feedback from others regarding ideas or suggestions.
• Documents status and results accurately and succinctly.
• Provides clear and accurate data regarding product and process measurables.
• Uses good judgment regarding how to proceed on assigned tasks, and when to alert others.
• Displays curiosity about technology, the industry and competitive knowledge. Adapts to change.
• Actively listens, asks questions, and clarifies communication to ensure understanding.
• Documents work accurately and builds effective cross-functional relationships.
• Communicates project details and roadblocks effectively to the team and supervisor.
• Prepares for meetings with necessary materials (physical products, prototypes and tools) and seeks guidance when needed.

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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