Quality Technician II- Medical Device

Join our team and contribute to advancing healthcare innovation through meticulous testing and quality assurance. Apply today!

Job Purpose: We are seeking a highly motivated individual to join our high-performance cross-functional team on a contract basis, performing routine medical device particulate testing. This role ensures the delivery of the highest quality results to our customers. Ideal candidates thrive in a fast-paced environment, demonstrate excellent documentation practices, and possess exceptional attention to detail.

Responsibilities:

• Perform routine testing assignments requiring basic interpretation of established procedures.

• Gather and record data, analyze results, and verify & report test results.

• Utilize broad judgment in troubleshooting assignments.

• Create and maintain data files and forms.

• Communicate with a wide variety of personnel within and outside the plant.

• Identify areas of improvement and participate in continuous improvement projects.

• Use documentation systems to research information and generate Change Requests.

• Assist in developing and qualifying data sheets, equipment/fixtures, visual standards, and test methods.

• Initiate, investigate, and assist in the generation and completion of NCEPs.

• Support engineers in failure analysis and CAPA activities.

• Assist with product failure analysis.

• Communicate testing results to teams.

• Support process and product qualification activities.

• Perform special quality initiatives with guidance.

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with Quality Policy and documented quality processes and procedures.

• Employ basic analytical lab skills such as reading a meniscus, pipetting, using a balance, using a stir plate, etc.

Required Qualifications:

• 1 year of experience with an AA degree or an equivalent combination of education/work experience.

• Prior experience in a lab environment including analytical laboratory skills (weighing, pipetting, scientific method, etc.).

• Knowledge of Microsoft Office (Word, Excel, Outlook).

• Must be physically able to lift up to 35 lbs.

• Must be able to stand for 8 hours.

Preferred Qualifications:

• DV test protocol training and execution experience.

• Strong problem-solving skills.

• Quick learner, willing to learn current test processes and procedures in a regulated environment.

• Ability to multitask between projects in different stages of development.

• Experience analyzing and fulfilling documentation requirements.

• Ability to communicate detailed information to project teams.

• Ability to work in a team environment interacting with engineers and technicians.

• Prior experience in test documentation through lab notebooks or reports.

• Experience in the medical device industry, preferably testing medical devices.

• Operate and maintain test equipment.

• Chemistry/Biology experience and basic analytical lab skills such as reading a meniscus, pipetting, using a balance, using a stir plate, etc.

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