TEC Group
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 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 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 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.
Quality Systems Duties and Responsibilities: 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.
Basic Qualifications: • Degree or equivalent work experience in related discipline and 1+ 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.
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 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 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 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.
Quality Systems Duties and Responsibilities: 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.
Basic Qualifications: • Degree or equivalent work experience in related discipline and 1+ 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.