Quality Technician (Manufacturing)

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. 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, authorize release of finished product/processes and execute calibration and environmental monitoring processes.SHIFT: 10:00pm - 6:30am (3rd shift) + overtime as needed**PAY: **$20 - 25hr + quarterly bonus & overtime as needed**LOCATION: **7405 Page Ave St. Louis, MOWhat You'l 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:High School Diploma with +3 years of experience in a manufacturing/repair environment/other technical production OR Associates Degree with +1 year of experience in a manufacturing or repair environment.Experience with math including ratios, proportions and basic algebra.Ability to:- Work in a fast-paced environment with strict deadlines.Read and comprehend written instructions, safety warning labels, and machine instruction manuals.Generate detailed, high-quality documentation.Work with others in analyzing and solving technical problems.Collaborate with others and works in a professional manner to support team actions.Work with minimal supervision, and have basic computer skills, including Excel and Word.Cross train in aseptic department.May be expected to move, carry, and lift approximately 50 pounds.Preferred:Previous experience in a regulated industry: ISO 13485 & FDA specifically.Previous experience in aseptic gowning.Previous experience with GDP (good documenting processes).Expereince working in chemical manufacturing.Other:Position requires bending, walking, standing, sitting, typing, hand manipulation and, visual acuity.Ability to lift, push, and pull between 25lbs to 50lbs as needed.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 PayExtensive Paid Time Off and (9) added holidaysExcellent Healthcare, Dental and Vision BenefitsLong/Short Term disability coverage401(k) with company matchMaternity & Paternal LeaveAdditional add-on benefits/discounts for programs such as Pet InsuranceTuition Reimbursement and continued educations programsExcellent opportunities for advancement and stable long-term careerYou should be proficient in:ISO 13485FDA RegulationsISO 9001 Certification ExperienceGood Manufacturing Practices (GMP)Machines & technologies you'll use:Calipers and Micrometers #J-18808-Ljbffr Torrey Holistics