Senior Quality Technician (49395)
Senior Quality Technician (49395)
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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 DHRs 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
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.
Pay range for this opportunity is$22.68-$29.35.This position is eligible forbonus participation.
Minimum pay rates offered will comply with county/city minimums if higher than range listed. Pay rates are based on a number of factors including but not limited to local labor market costs years of relevant experience education professional certifications foreign language fluency etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits:STERIS Benefits
STERIS is an Equal Opportunity 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 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 locations HR Office during normal business hours.
Required Experience:
Senior IC
Employment Type
Full Time
