Flexibility to start earlier than 8:00am if the candidate wants
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.
Job 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 BSC 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 BSC 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.
Education & Qualifications
Required
1 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 35 lbs.
Must be able to stand for 8 hours.
Preferred:
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.