Quality Technician

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