What are the responsibilities and job description for the Quality Technician position at STERIS?
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 Quality Technician is responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards.
- The Quality Technician supports production and quality operations by assisting in performing and documenting problem solving investigations, conducting pre-reviews of Customer product and run set-up and final acceptance/run release through review of run records/device history records.
- Quality Technicians assist in identifying, documenting and investigating non-conformances, Customer complaints, CAPAs and internal/external audit findings. They work with operations and quality team members to perform and document problem-solving investigations and continuous improvement initiatives. In addition, to performing run releases, Quality Technicians may execute review of calibration and operating logs.
Duties
- Conducts pre-review on incoming product to confirm compliance to the Customer’s processing specifications, verifies calculations, correct dose range, approved product codes, dosimeter placements and special instructions.
- Releases processing runs after product has been processed, ensuring all processing parameters and Customer specifications have been met and the run file (device history record) is accurate and complete.
- In Lab facilities, review and release laboratory reports, ensuring tests comply with requirements and Customer requests.
- Assists in Quality investigations, associated problem-solving activities and continuous improvement initiatives.
- Identifies, documents and investigates non-conformances to establish sustainable corrective actions. Supports investigations into Customer complaints and internal/external audit observations.
Duties - cont'd
- Assist in the development (and revisions to) quality system policies and procedures.
- Executes review of operating logs (i.e. spectrophotometer, pre-conditioning, aeration), preventive maintenance schedules, maintenance work orders, and site calibration activities to ensure timely and accurate recordkeeping. Responsible to escalate matters of non-compliance to site Quality Lead/Manager.
- Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
- Complete other duties as assigned.
Education Degree
- High School Diploma or GED
Required Experience
- 4 years relevant technical/scientific experience.
Preferred Experience
- Associate Degree plus 1 Year experience in Manufacturing or Processing Environment preferred.
Skills
Business competencies:
- Ability to work in a fast-paced, regulated environment with strict deadlines.
- Mathematical skills including ratios, proportions, basic algebra.
- Ability to generate detailed, high-quality documentation.
- Ability to work with others in analyzing 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
Pay range for this opportunity is $23-$27
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 is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 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.
Salary : $23 - $27
