Quality Technician - Line & Packaging

Job Description

Job Description

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.

Position Summary:

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: 5am - 1:30pm Monday through Friday & overtime as business needs

*Training may require 6/7/8am start times as needed

LOCATION: 14905 28th Ave North Plymouth, MN

PAY: $22.47 - $27.76 (paid bi-weekly) & bonus participation

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.
• Complete other duties as assigned.

**Skills, Abilities, and Experience: **

Required:

• Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks AND a high school diploma or equivalent.- Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks AND an associate degree.

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

• 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.

  • collaborate with others.

  • work in a professional manner to support team actions.

  • effectively manage work tasks.

Preferred:

• Previous experience working as a Quality Technician in a regulated, chemical manufacturing industry.

• Experience working in systems like Trackwise, SAP, and Propel to manage products and track work instructions.

• Continuous improvement or process improvement experience in a work setting.

• Expereince working with Lean Manufacturing principles.

• ISO/FDA audit experience.

Other:

• Lifting, pushing, and/or pulling 25-50lbs.
• Bending, walking, standing, sitting, typing, hand manipulation, and/or visual acuity may be required in this role.
• 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 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

You should be proficient in:

• ISO 13485
• Manufacturing Instruction (MI)
• FDA Regulations
• Mechanical Testing
• Lean Manufacturing Principles
• ISO 9001 Certification Experience
• Good Manufacturing Practices (GMP)
• Experience in a Manufacturing Environment

Machines & technologies you'll use:

• ERP Software
• Quality Control Software