Quality Technician II
Job Description :
Flexibility to start earlier in the day (before : am)
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.
Responsibilities will include :
- 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 client 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.
- Assist 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.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the client 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.
Required qualifications :
- year with 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) required.
- Must be physically able to lift up to lbs.
- Must be able to stand for 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.
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