Technician - Quality Technician II

Quality Technician II

Job Purpose
This individual will work within a high-performance cross-functional team performing routine medical device particulate testing ensuring delivery of the highest quality result to the customer. We are seeking a highly motivated individual who thrives in a fast-paced environment, with excellent good documentation practices, and exceptional attention to details.

Key Responsibilities:

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

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

• Assignments require broad judgment in troubleshooting.

• Create and maintain data files and forms.

• Communicate with a wide variety of personnel in and outside of 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 qualify data sheets, equipment/fixtures, visual standards, and test methods.

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

• Assist with product failure analysis.

• Communicate testing results to teams.

• Assist engineers in failure analysis and CAPA activities, including assignment as a CAPA project member.

• Support process and product qualification activities.

• Serve support roles during external audits:
Document retriever, auditee.

• Perform "special” quality initiatives with guidance.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

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

Basic Qualifications:

• AA Degree or equivalent work experience in related discipline and 3+ year of related experience.

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

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

• 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 the current test processes and procedures in a regulated environment.

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

• Demonstrated experience analyzing and fulfilling documentation requirements.

• Ability to communicate detailed information to the 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 medical device industry preferably testing medical devices.

• Operate and maintain test equipment.

• Chemistry/Biology experience.