Quality Technician – Medical Device

Megan Patterson

Technician
Burnsville, MN
Posted 2 weeks ago

Imricor is the first and only company in the world to bring commercially viable and safe iCMR products to the catheter ablation market.  As we continue to commercialize Imricor is growing and looking for employees who want to help bring this therapy to patients all over the world. We value all applicants and encourage diverse candidates to apply.

Basic Function

Quality Technician will be responsible for supporting Imricor’s product manufacturing. Primary responsibilities include receiving materials, performing component inspection, equipment calibration/maintenance, and manufacturing quality support. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Perform product and component receiving and inspections in accordance with defined policy and procedures. This includes receiving and inspecting components, subassemblies, labeling, and finished products to support production. Inspections will occur in cleanroom, non-cleanroom production areas, and warehouse receiving and quarantine areas. Use tools such as calipers, micrometers, gauges, and tensile testers.
  • Perform installation, calibration, testing, and troubleshooting of laboratory instruments and equipment.
  • Operate various test instruments and fixtures. Develop test procedures for inspection.
  • Assist with documenting material requirements or inspection criteria, as needed.
  • Assist with process monitoring and measurement analysis of data, as needed.
  • Monitor calibration and maintenance of test equipment and fixtures.
  • Maintain, support, and continuously improve the calibration and preventative maintenance program for example, a) coordinate calibration work orders, calibration certificates, and calibration files, b) assisting and supporting coordination of on-site and off-site calibration and repair activities, c) serve as a contact for customers, vendors and equipment service personnel.
  • Manage and perform routine calibration and preventative maintenance of equipment and tooling to ensure proper function within specifications. Troubleshoot and diagnose causes of equipment failures and apply corrective actions. Resolve equipment breakdowns in efforts to minimize downtime.
  • Perform calibration audits and in-process calibration audits to ensure compliance.
  • Order and monitor replacement/spare calibration equipment as required.
  • Initiate related documentation changes. Maintain accurate documentation and records.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

  • Two-year degree or equivalent experience.
  • Minimum of 3 years’ experience in quality and manufacturing environment, including Good Documentation Practice skills to maintain neat and accurate records and files.
  • Knowledge and experience with inspection concepts, general measuring tools and test equipment, and maintenance and calibration programs.
  • Knowledge of ISO 13485 requirements preferred.
  • Experience with Microsoft Office: Word, Excel, PowerPoint.
  • Must be able to read, write and speak fluent English.

Working Conditions

  • Light work, exerting up to 20 lbs. of force or less.
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/ distinguish colors.
  • Requires finger dexterity, repetitive motion, talking and hearing.
  • 50% of time requires viewing and working at computer screen.
  • Significant work pace & pressure due to deadlines.

Basic Function

Quality Technician will be responsible for supporting Imricor’s product manufacturing. Primary responsibilities include receiving materials, performing component inspection, equipment calibration/maintenance, and manufacturing quality support. This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Perform product and component receiving and inspections in accordance with defined policy and procedures. This includes receiving and inspecting components, subassemblies, labeling, and finished products to support production. Inspections will occur in cleanroom, non-cleanroom production areas, and warehouse receiving and quarantine areas. Use tools such as calipers, micrometers, gauges, and tensile testers.
  • Perform installation, calibration, testing, and troubleshooting of laboratory instruments and equipment.
  • Operate various test instruments and fixtures. Develop test procedures for inspection.
  • Assist with documenting material requirements or inspection criteria, as needed.
  • Assist with process monitoring and measurement analysis of data, as needed.
  • Monitor calibration and maintenance of test equipment and fixtures.
  • Maintain, support, and continuously improve the calibration and preventative maintenance program for example, a) coordinate calibration work orders, calibration certificates, and calibration files, b) assisting and supporting coordination of on-site and off-site calibration and repair activities, c) serve as a contact for customers, vendors and equipment service personnel.
  • Manage and perform routine calibration and preventative maintenance of equipment and tooling to ensure proper function within specifications. Troubleshoot and diagnose causes of equipment failures and apply corrective actions. Resolve equipment breakdowns in efforts to minimize downtime.
  • Perform calibration audits and in-process calibration audits to ensure compliance.
  • Order and monitor replacement/spare calibration equipment as required.
  • Initiate related documentation changes. Maintain accurate documentation and records.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Qualifications

  • Two-year degree or equivalent experience.
  • Minimum of 3 years’ experience in quality and manufacturing environment, including Good Documentation Practice skills to maintain neat and accurate records and files.
  • Knowledge and experience with inspection concepts, general measuring tools and test equipment, and maintenance and calibration programs.
  • Knowledge of ISO 13485 requirements preferred.
  • Experience with Microsoft Office: Word, Excel, PowerPoint.
  • Must be able to read, write and speak fluent English.

Working Conditions

  • Light work, exerting up to 20 lbs. of force or less.
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/ distinguish colors.
  • Requires finger dexterity, repetitive motion, talking and hearing.
  • 50% of time requires viewing and working at computer screen.
  • Significant work pace & pressure due to deadlines.

To apply, please submit your resume and cover letter documents below.

Imricor is an equal opportunity employer and encourages diverse candidates to apply.

Job Features

Job CategoryQuality
Position reports to:Quality Manager
Position Status:Non-Exempt

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