QC Scientist
St. Louis, MO, US, 63133
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 Lead / QC Scientist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.
This position is responsible for generating leading quality control initiatives with minimal supervision including second sourcing, developing test methods and troubleshooting lab and product issues in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to: developing test methodologies and validation methods, and audits.
Duties
- Assist with developing test methodologies and procedures
- Assists / trains Lab Techs and Specialist
- Works with QS on internal and external audits and audit training
- Assists with developing and validating methods
- Support and / or develop chemical testing procedures
- Support and /or develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering
- Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant
- Troubleshoots & calibrates Lab equipment
- Maintain and order lab supplies
- Lead: Assists with directing work of lab employees
- Lead: In supervisor’s absence will manage day to day operations including, scheduling, submit requisition to obtain lab supplies, and reviewing documentation
Education Degree
- Bachelor's Degree in Science
Requirements
- Minimum 6 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required.
- Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics
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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.
St. Louis, MO, US, 63133
Nearest Major Market: St Louis
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QC, Infection Control, Chemical Research, Laboratory, Scientist, Quality, Healthcare, Engineering, Science