Senior Quality Engineer

The Senior Quality Engineer in our St. Louis, Missouri facility 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 mainly focuses on leading external audits, complaints process, and CAPA investigations.

This position requires working onsite in our St. Louis, Missouri facility Monday through Friday 7:00am to 4:30pm.

• 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.
• Use 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.
• Perform all other duties as assigned.

Required:

• BS Chemical Engineering, Biochemical Engineering, or Biomolecular Engineering.
• Minimum of 6 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Minimum of 6 years of experience working in an ISO certified environment required.

Preferred:

• Minimum of 1 year of experience working in a manufacturing environment.
• Minimum of 6 years of experience with medical device, pharmaceutical or other regulated industries preferred.
• Experience with statistical analysis software and Visio preferred.
• ASQ, QSR or familiarity with QSR/GMP regulations preferred.
• Ability to manage external Customer and FDA audit process.
• Ability to manage the complaint handling processes to ensure Customer responsiveness and product and process improvements

Other:

• Ability to think critically and prioritize tasks, keeping the impact to the Customer at the forefront.
• Balance, manage, and execute continuously changing priorities, while collaborating with Production.
• 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.

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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