Production Operator Assembler III (Cleaning & Passivation) - 2nd Shift

Quality Tech Services, LLC

BLOOMINGTON (MN)

On-site

USD 28,000 - 39,000

Full time

4 days ago
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Job summary

Quality Tech Services, LLC is seeking a Production Operator Assembler III for its Bloomington, Minnesota facility. This advanced role requires SME-level skills across multiple processes and mentors team members on procedures, equipment, and quality standards.

The 2nd shift runs from 2:45pm to 1:15am with a focus on continuous improvement and ISO/cGMP compliance. The position emphasizes training, documentation, and cross-training to support high-quality assembly and manufacturing operations for

Qualifications

  • 3+ years of manufacturing, assembly, or cleanroom experience.
  • Experience in training and mentoring others.
  • Ability to work in a manufacturing environment.
  • Ability to read, write, and follow written instructions in English.

Responsibilities

  • Perform visual and/or dimensional inspection using microscopes, gauges, calipers, or other measurement tools.
  • Serve as a resource for resolving technical issues and improving processes.
  • Train and mentor new and existing employees on procedures, equipment, and quality standards.
  • Complete detailed documentation and ensure compliance with ISO/cGMP standards.
  • Participate in continuous improvement initiatives and implement process enhancements.
  • Crosstrain and assist in onboarding new team members.
  • Maintain an organized, clean work area following 5S expectations.
  • Participate in required training and company meetings.
  • Read, understand, and follow work instructions, standard work, and applicable quality/ISO/cGMP requirements.
  • Participate in root cause analysis and corrective action implementation.
  • Support and comply with the Quality System, ISO, and medical device regulatory requirements.
  • Communicate issues with materials, equipment, or processes promptly.
  • Perform other duties as assigned.
  • Assemble and package components and medical devices with increased complexity per specifications.
  • Operate advanced manual and semi-automated equipment.
  • Perform in-process quality checks and resolve assembly issues.
  • Set up and operate production equipment, including loading programs and adjusting parameters.
  • Monitor and troubleshoot machine performance and elevate issues as needed.
  • Perform operator-level preventive maintenance.
  • Execute advanced secondary operations (e.g., trimming, deburring, cleaning, passivation, laser marking, laser welding, label generation & inspection, and/or finishing of components).
  • Use precision measurement tools (micrometers, digital calipers, drop indicators, pull testers, etc.) for verification.
  • Utilize testing equipment and enter data in the applicable system.

Skills

Training and mentoring
English literacy

Job description

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS was founded in 2001 and is part of the Cretex Medical family of companies.

  • Purpose: To have a positive impact on people.
  • Mission:Make it easier to get products to patients.
  • Values: Integrity, Collaboration, Communication, & Leadership

Learn more at www.qtspackaging.com and www.cretexmedical.com.

Responsibilities

Position Summary

The Production Operator Assembler III is an advanced-level role that requires advanced technical skills. This position serves as a subject matter expert (SME) in multiple processes, provides training and mentorship to team members, and supports process optimization and quality improvement initiatives.. This position will be based out of our facility located in west Bloomington, Minnesota (55438). The hours for 2nd shift are 2:45pm-1:15am.

Essential Job Functions

Core Responsibilities (Applies to All Areas)

  • Perform visual and/or dimensional inspection using microscopes, gauges, calipers, or other measurement tools, as required.
  • Serve as a resource for resolving technical issues and improving processes.
  • Train and mentor new and existing employees on procedures, equipment, and quality standards.
  • Complete detailed documentation and ensure compliance with ISO/cGMP standards.
  • Participate in continuous improvement initiatives and implement process enhancements.
  • Crosstrain and assist in onboarding new team members.
  • Maintain an organized, clean work area following 5S expectations.
  • Participate in required training and company meetings.
  • Read, understand, and follow work instructions, standard work, and applicable quality/ISO/cGMP requirements.
  • Participate in root cause analysis and corrective action implementation.
  • Support and comply with the Quality System, ISO, and medical device regulatory requirements.
  • Communicate issues with materials, equipment, or processes promptly.
  • Perform other duties as assigned.

The following responsibilities may vary by operating company and may not apply in all cases. Other responsibilities may also be assigned, but are not listed below.

Assembly Responsibilities

  • Assemble and package components and medical devices with increased complexity per specifications.
  • Operate advanced manual and semi-automated equipment.
  • Perform in-process quality checks and resolve assembly issues.

Production Operations Responsibilities

  • Set up and operate production equipment, including loading programs and adjusting parameters.
  • Monitor and troubleshoot machine performance and elevate issues as needed.
  • Perform operator-level preventive maintenance.

Secondary Operations Responsibilities

  • Execute advanced secondary operations (e.g., trimming, deburring, cleaning, passivation, laser marking, laser welding, label generation & inspection, and/or finishing of components).
  • Use precision measurement tools (micrometers, digital calipers, drop indicators, pull testers, etc.) for verification.
  • Utilize testing equipment and enter data in the applicable system.
Qualifications

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

  • 3+ years of manufacturing, assembly, machine operation, or cleanroom experience.
  • Experience in training and mentoring.
  • Ability to work in a manufacturing environment.
  • Ability to read, write, and follow written instructions in English.
  • Clear
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