Quality Technician
STERISAbout the role
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 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. This role 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, authorize release of finished product/processes and execute calibration and environmental monitoring processes.
Hours: Monday - Friday 6am - 2:30pm + rotating Saturdays every 4 weeks
Pay: $20.43 + $26.44hr
Location: 7501 & 7405 Page Ave St. Louis, MO
Hire Type: Full time/direct hire
What You'll Do:
- 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.
- Investigates production line stoppages to identify corrective actions.
- Identifies and documents product and process non-conformances.
- Participates on a Material Review Board to review and process non conformance reports.
- Reviews DHR’s and supports batch record release.
- Enters and retrieves Quality data from local and global systems.
- Performs site calibration activities and recordkeeping.
- Executes environmental monitoring processes and recordkeeping.
- Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
Skills, Abilities, and Experience:
Required:
- Associates Degree in Engineering or Scientific fields + 1yr of experience in manufacturing or repair environment or other technical production tasks.
- HS Diploma or GED equivilant + 3yrs of expereince in a manufacturing or repair environment.
- Experince with mathematical skills inlcuding ratios, proportions and basic algebra.
- PC experience and working familiarity of common desktop applications including Excel and Word.
- Ability to work in a fast-paced environment with strict deadlines.
- Ability to generate detailed, high-quality documentation.
- Ability to work with others in analyzing and solving technical problems.
Preferred:
- Previous expereince working in a regulated environment (FDA/ISO/EU MDR).
- Knowledge and experience working in Aseptic gowning.
- Experience with GDP (Good Documentation Practices) guidelines.
- Knowledge of 5S manufacturing practices and/or experience working with them in a professional setting.
Other:
- Specific Skills & Competencies:
- Collaborate with others. Work in a professional manner to support team actions.
- Effectively manage work tasks.
- Attention to detail.
- Drive for continuous improvement.
- Working Condidtions:
- Manufacturing/Operations Center
- Physical Requirements:
- Lifting, Pushing, & Pulling 25 - 50lbs
- Bending, Walking, Standing, Sitting, Typing, Hand Manipulation, Visual Acuity, Feet Manipulation
What STERIS Offers:
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:
- 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 company match
- Maternity & Paternal Leave
- Additional add-on benefits/discounts for programs such as Pet Insurance
- Tuition Reimbursement and continued educations programs
- Excellent opportunities for advancement and stable long-term career
Pay range for this opportunity is $20.43 - $26.44. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range list
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