Description:
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 results to the customer. We are seeking a highly motivated individual who thrives in a fast-paced environment, with excellent documentation practices, and exceptional attention to detail.
Key Responsibilities:
" Perform routine testing assignments requiring basic interpretation of established procedures.
" Gathers and records data, analyzes results, and verifies and reports 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 qualifying 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 with 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+ years 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 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 the medical device industry, preferably testing medical devices.
" Operate and maintain test equipment.
" Chemistry/Biology experience.