Quality Technician

Actalent; Minnesota; On-site; USD 42,000 - 65,000; Full time

Job summary

Actalent in Minnesota seeks a Medical Device Laboratory Technician to join a high-performance team. The role involves routine particulate testing of medical devices, strict documentation, and collaboration with engineers to ensure product quality and patient safety.

You will support CAPA activities and assist in audit readiness while maintaining compliance with regulatory standards. The ideal candidate has an AA degree or equivalent with 3+ years in a lab setting, strong analytical skills, and

Qualifications

• Associate degree or equivalent experience with 3+ years in a related lab role.
• Hands-on analytical lab skills including weighing, pipetting, and applying the scientific method.
• Ability to perform analytical testing with strong attention to detail and accuracy.
• Experience using basic measurement tools such as calipers.
• Chemistry and biology concepts relevant to lab testing and medical devices.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Familiarity with DV test protocols in regulated environments.
• Strong problem-solving and troubleshooting abilities.
• Ability to work under regulatory guidelines and document thoroughly.

Responsibilities

• Perform routine medical device particulate testing assignments following established procedures.
• Gather and record data with strict documentation practices and prepare test reports.
• Troubleshoot test issues and equipment, escalate when needed.
• Create and maintain data files, forms, and test documentation for traceability.
• Communicate testing results to project teams and stakeholders.

Skills

Analytical testing

Documentation practices

Attention to detail

Laboratory skills

Pipetting

Calipers

Education

Associate degree (AA) or equivalent

Tools

Calipers

Balance

Pipettes

Stir plate

DV test protocol training

Job description

Job Description

Job Description

Job Title: Medical Device Laboratory Technician

Job Description

This role is part of a high-performance cross-functional team responsible for routine particulate testing of medical devices to ensure the highest quality results. The position is ideal for a highly motivated individual who thrives in a fast-paced, regulated environment, demonstrates strong documentation practices, and maintains exceptional attention to detail while supporting patient safety and product quality.

Responsibilities

• Perform routine medical device particulate testing assignments, applying basic interpretation of established procedures to ensure accurate and reliable results.
• Gather and record test data with strong adherence to good documentation practices, analyze results, verify findings, and prepare clear and accurate test reports.
• Exercise broad judgment in troubleshooting test issues and equipment problems, escalating and resolving them in a timely manner.
• Create, maintain, and organize data files, forms, and test documentation to support traceability and compliance requirements.
• Communicate effectively with a wide range of personnel within and outside the plant to coordinate testing activities and share information.
• Identify opportunities for improvement in testing processes and participate in continuous improvement projects to enhance efficiency and quality.
• Use documentation systems to research information, generate change requests, and support updates to procedures and test methods.
• Assist in developing and qualifying data sheets, equipment fixtures, visual standards, and test methods used in laboratory testing.
• Initiate, investigate, and assist in the generation and completion of quality-related records and deviation documentation, ensuring thorough follow-up.
• Assist with product failure analysis by performing tests, gathering data, and contributing to root cause investigations.
• Communicate testing results clearly and promptly to project teams, engineers, and other stakeholders.
• Support engineers in failure analysis and corrective and preventive action (CAPA) activities, including serving as a CAPA project team member when assigned.
• Support process and product qualification activities by executing test protocols and documenting results in accordance with regulatory requirements.
• Serve in support roles during external audits, including acting as a document retriever and auditee, and ensuring readiness of test documentation.
• Perform special quality initiatives under guidance, contributing to projects that enhance product and process quality.
• Consistently demonstrate a primary commitment to patient safety and product quality by maintaining compliance with documented quality policies, processes, and procedures.
• Employ basic analytical laboratory skills, such as reading a meniscus, pipetting accurately, using a balance, and operating a stir plate and other lab equipment.
• Operate and maintain test equipment to ensure proper function, calibration, and reliability for ongoing testing activities.

Essential Skills

• Associate degree (AA) or equivalent work experience in a related discipline, with 3+ years of related experience.
• Prior experience working in a laboratory environment, including hands-on analytical laboratory skills such as weighing, pipetting, and applying the scientific method.
• Ability to perform analytical testing with strong attention to detail and accuracy.
• Experience using basic measurement tools such as calipers.
• Chemistry and biology experience relevant to laboratory testing and medical device evaluation.
• Knowledge and practical use of Microsoft Office applications, including Word, Excel, and Outlook.
• DV test protocol training and execution experience in a regulated environment.
• Strong problem-solving skills with the ability to troubleshoot test methods and equipment issues.
• Ability to quickly learn and follow current test processes and procedures in a regulated setting.
• Ability to multitask and manage multiple projects at different stages of development.
• Demonstrated experience analyzing and fulfilling documentation requirements, including compliance with quality standards.
• Ability to communicate detailed technical and testing information clearly to project teams and stakeholders.
• Ability to work effectively in a team environment, collaborating with engineers and technicians.
• Prior experience in test documentation through laboratory notebooks or formal reports.
• Experience in the medical device industry, preferably with direct involvement in testing medical devices.
• Ability to operate and maintain laboratory test equipment