Quality Control Inspector 47134
Quality Control Inspector 47134
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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 Inspector 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 Inspector supports the manufacturing operations of electromedical devices by performing incoming component inspections inprocess controls of products using advanced measuring instruments.Identifies and document component process and product nonconformances and lead investigation/rootcause countermeasure activities. Collaborates with manufacturing engineering team in troubleshooting investigations and manufacturing process problem solving.Is responsible for maintaining the calibration status of monitoring and measuring instrumentation in the quality inspection and production department interfacing directly with suppliers for calibration.
Duties
- Conducts complex incoming component and inprocess product inspections.
- Initiate and supports quality investigations and associated problemsolving / rootcause activities.
- Generates incoming inspection plans.
- Identifies and documents product and process nonconformances.
- Identifies opportunities for process continuous improvement.
- Participates on a Material Review Board to review and process non conformance reports.
- Supports supplier quality improvements through SCARs and other site actions.
- Oversees DHR reviews and batch record release.
- Tracks trends and reports quality data for assigned areas.
- Performs site calibration activities and recordkeeping for inspection equipment.
- Executes environmental monitoring processes and recordkeeping.
- Complete other duties as assigned.
Education Degree
Required Experience e Competencies
- 13 year experience required in a quality/manufacturing environment or other technical production tasks.
Ability to work in a fastpaced environment with strict deadlines
Ability to generate detailed high quality documentation
Ability to work with others in analysing and solving technical problems
Teamwork: Collaborates with others. Works in a professional manner to support team actions.
Effectively manages work tasks. Is detail oriented and strives for continuous improvement.
PC experience and working familiarity of common desktop applications including Excel and Word
Additional Information
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 sex sexual orientation gender identity genetic information and any other category protected by state or local law.
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 17000 associates and Customers in more than 100 countries.
STERIS strives to be an Equal Opportunity Employer.
Employment Type
Full Time
