QC Laboratory Manager

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 QC Laboratory Manager is responsible for assisting in administration of the quality functions at our St. Louis site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role is responsible for leading all aspects of the quality control laboratory within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on QC Lab quality improvement and Good Laboratory Practices. 

What You Will Do

• Lead the organization’s QC laboratory staff to ensure all products are tested in accordance with company policy and Good Laboratory Practices  

• Work closely with site senior management to provide strategic direction and development, and awareness of the QC Lab . 

• Provide coaching, mentoring and leadership to the Quality staff. 

• Lead the QC Lab’s continuous improvement process; including data analysis, improvement projects and process capability to improve key metrics as measured by the quality lab dashboard. 

• Manage the OOS process to ensure operational responsiveness and product and process improvements.  

What You Will Do - con'd

•    Lead and implement effective production and process controls. 
•    The position requires a level of authority to conduct and direct required activities such as quality planning, personnel management and regulatory compliance.  
•    Serves as the contact point for outside vendors, consultants and auditors. 
•    Assists with the developing, reviewing and approving test methodologies and procedures. 
•    Works with quality staff on internal and external audits and audit training. 
•    Assists with developing, reviewing, approving and validating lab methods. 
•    Performs other duties as assigned. 
 

Education Degree

Bachelor's Degree in Science

Required Experience

• Minimum 8 years relevant lab testing and management in a regulated industry (i.e. FDA/ISO13485) required. 
• Prefer minimum eight (8) years of combined Manufacturing and/or Quality Systems experience. 
• Experience working in an ISO certified environment required. 

 

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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.