The 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 Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing. Quality Technicians assist in identifying and documenting process and product non-conformances. They work with operations team members to perform and document problem-solving investigations. In addition, Quality Technicians may review device history records (DHR), authorize release of finished product/processes and execute calibration and environmental monitoring processes.
What You'll Do as a Quality Technician* Assists in production line Quality investigations and associated problem-solving activities.
* May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
* Investigate production line stoppages to identify corrective actions.
* Identifie and document product and process non-conformances.
* Participate in a Material Review Board to review and process non-conformance reports.
* Reviews DHR's and supports batch record release.
* Enter and retrieve Quality data from local and global systems.
* Perform site calibration activities and recordkeeping.
* Execute environmental monitoring processes and recordkeeping.
* Verifiy calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
* Complete other duties as assigned.
Required:
* Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
* Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an associate degree.
Preferred:
Experience working in a regulated industry (i.e. FDA/13485, ISO 9001)
What STERIS OffersWe value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.
Here is a brief overview of what we offer:
* Market Competitive Pay
* Extensive Paid Time Off and (9) added Holidays
* Excellent Healthcare, Dental and Vision Benefits
* Long/Short Term Disability Coverage
* 401(k) with a company match
* Maternity and Paternity Leave
* Additional add-on benefits/discounts for programs such as Pet Insurance
* Tuition Reimbursement and continued education programs
* Excellent opportunities for advancement in a stable long-term career
Pay range for this opportuniity is $21.00 - $23.00 per hour. 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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