Job Description

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.

HOURS: 1st shift (5-6am start) + overtime as needed

LOCATION: 41905 28th Ave North Plymouth, MN

PAY: $23 - $29hr (biweekly pay) + bonus

HIRE TYPE: Direct, full time.

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:

• 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.

• Ability to- work in a fast-paced environment with strict deadlines.

  • generate detailed, high-quality documentation.
  • work with others in analyzing and solving technical problems.

• PC experience and working familiarity of common desktop applications including Excel and Word.

• Experience with mathematical skills including ratios, proportions and basic algebra.

Preferred:

• Experience working in a chemical manufacturing/production environment.
• Continuous Improvement/Process Improvement experience.
• Attention to detail.
• Hazardous materials experience.
• Experience working with FDA (CFRA20/GMP&GDP) and/or ISO or similarly regulations.
• Experience utilizing Trackwise, SAP, Propel systems.

Other:

• Lifting, Pushing, Pulling 25-50lbs
• Bending,Walking,Standing,Sitting,Typing,Hand Manipulation
• Visual Acuity(mostly in reference to investigations/picking through cases/moving some cases/boxes as needed)
• This is a safety sensitive position

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 (PTO) and (9) added Holidays.

• Excellent Healthcare, Dental, and Vision Benefits.

• Long/Short term disability coverage.

• 401(k) with a company match.

• Maternity & Parental Leave.

• Additional add-on benefits/discounts for programs such as Pet Insurance.

• Tuition Reimbursement and continued education programs.

• Opportunity for advancement in a stable long-term career.

You should be proficient in:

• Continuous Improvement
• 5 Why (Root Cause Analysis Method)
• FDA Regulations
• Good Manufacturing Practices (GMP)
• Microsoft Excel
• 5S
• CFRA20
• chemical manufacturing
• GDP
• ISO Regulation
• microsoft office
• basic algebra

Machines & technologies you'll use:

• Propel
• Trackwise
• SAP