Quality Technician II

Job Description

Job Summary:

• 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.

Duties and 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 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 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 Client’s 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.