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.
Position Summary
The Senior Quality Engineer is responsible for managing processes, resolving product issues and leading projects in a chemical manufacturing facility to maintain and improve product quality and the quality system in accordance with the requirements of, as appropriate, IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads Customer complaint, Non-Conformance and CAPA investigations, supplier quality improvement actions, production and process control improvements, and product quality improvements with the use of statistical techniques and other accepted quality principles within a scientific environment. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
Duties

• Serves as the Core Team Member on cross-functional new product development teams with focus on the execution of quality plans and design transfer specific to blended pharmaceutical detergents, disinfectants and sterile products.
• Develops, documents, and implements statistically valid sampling plans, designed experiments, capability studies, SPC, trend analysis and technical triage reports in support of product investigations and improvements.
• Leads investigation efforts, including root cause analysis, corrective actions and problem-solving activities for product and product-related manufacturing issues.
• Prepares detailed technical reports on investigation and communicate findings effectively to the stakeholders.
• Ensures compliance with regulatory standards and internal quality protocols throughout the manufacturing process.
• Works collaboratively with QA, production, R&D, Regulatory and other departments on various technical investigations.
• Reviews the current quality system to recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product quality.
• Leads projects focused on quality system and product quality improvements.
• Develops analyses and reports on product and process performance.
• Supports supplier audits and corrective actions as needed.
• Leads and supports internal and external quality system audits.
• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Potentially supervise and mentor Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
• Perform all other duties as assigned.

Education Degree

• Bachelor's Degree in Chemical Engineering or Chemistry

Required Experience

• 8 or more years of related experience in a process chemist or process engineering role within a chemical manufacturing or pharmaceutical industry
• 3 or more years of Quality Engineering experience
• 6-10 years of experience with medical device or production of pharmaceutical detergents, disinfectants and sterilants is highly preferred.
• 6-10 years of experience working in an ISO certified environment required.
• ASQ, QSR, Six Sigma black belt or familiarity with QSR/GMP regulations preferred.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.
If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
The full affirmative action program, absent the data metrics required by

• 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.