Job Description
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 Technician 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. The Senior Quality Technician supports manufacturing and servicing operations by coordinating problem-solving investigations and in-process and final QC product acceptance testing. Senior Quality Technicians open and lead investigations of product and process non conformances and assist in the implementation of improvements. This role also leads device history record review and coordinates the execution of calibration and environmental monitoring processes. In addition, Senior Quality Technicians track, trend and analyze quality data.
Duties
- May coordinate & conduct in-process and final QC product acceptance testing.
- Coordinates production line Quality investigations and problem-solving activities.
- Identifies and documents product and process non-conformance investigations.
- Opens and leads investigations of product and process non conformances.
- Coordinates Material Review Board to review and process non conformance reports.
- Leads DHR’s and batch record reviews to ensure compiance to regulations and standards.
- Analyzes and trends Quality data from local and global systems.
- Coordinates site calibration activities and recordkeeping.
- Coordinates environmental monitoring processes and recordkeeping.
- Make suggestions and support implementation of manufacturing and quality improvements.
- In Sterilization facilities, execute tests associated with dosimeter reading equipment, dosimeter calibrations and dosimeter batch acceptance.
- Complete other duties as assigned.
Education Degree
High School Diploma or GED
Associate's Degree in Engineering General
Required Experience - Minimum of five (5) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
- Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
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.
Job Tags
For contractors, Local area,