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.
- May coordinate & conduct in-process and final QC product acceptance testing.
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Coordinates production line Quality investigations and problem-solving activities.
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Identifies and documents product and process non-conformance investigations.
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Opens and leads investigations of product and process non conformances.
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Coordinates Material Review Board to review and process non conformance reports.
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Leads DHR’s and batch record reviews to ensure compiance to regulations and standards.
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Analyzes and trends Quality data from local and global systems.
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Coordinates site calibration activities and recordkeeping.
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Coordinates environmental monitoring processes and recordkeeping.
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Make suggestions and support implementation of manufacturing and quality improvements.
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In Sterilization facilities, execute tests associated with dosimeter reading equipment, dosimeter calibrations and dosimeter batch acceptance.
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Complete other duties as assigned.
Required:
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High School Diploma or GED.
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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.
Other:
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Ability to work in a fast-paced environment with strict deadlines
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Ability to analyze data, construct trends and pareto analyses.
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Ability to work with others in analyzing and solving technical problems.
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Collaborates with others. Works in a professional manner to support team actions.
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Effectively manages work tasks. Is detail oriented and strives for continuous improvement.
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
Here is just a brief overview of what we offer:
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Market Competitive Pay
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Extensive Paid Time Off and (9) added holidays
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Excellent Healthcare, Dental and Vision Benefits
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Long/Short Term disability coverage
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401(k) with company match
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Maternity & Paternal Leave
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Additional add-on benefits/discounts for programs such as Pet Insurance
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Tuition Reimbursement and continued educations programs
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Excellent opportunities for advancement and stable long-term career
Pay range for this opportunity is $23.09 - $29.88. This position is eligible for bonus 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
Open until position is filled.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity 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.
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