With minimal supervision and minimal instruction performs a variety of production assemblies and sub-assemblies. Works from drawings, diagrams, MPI’s and SOPs and in accordance with GMP regulations. Makes continuity checks on work in process and completed assemblies. Brings any discrepancies or nonconformities to the attention of supervisors in a timely manner. May conduct in process quality inspections in accordance with quality specifications.
DUTIES & RESPONSIBILITIES:
- Performs high level medical device assembly operations in accordance with approved manufacturing procedures and GMP requirements.
- Assists in implementing methods and procedures to control or modify the manufacturing process.
- Ensures that product quality is maintained through procedure adherence; identifies product quality deficiencies; raises potential quality issues to supervisor.
- Performs in-process quality checks on product at all levels using measurement tools of varying complexity i.e. optical measurement system, tensile tester
- Perform assembly operations expeditiously while maintaining high quality standards.
- Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
- May assist engineers to resolve line issues. Encouraged to openly suggest opportunities to improve product quality, reduce assembly cycle time and production efficiency.
- Performs assembly operations during product transfer and commercialization phase; provides assembly improvements and feedback to engineering.
- Maintain clean room integrity via proper gowning techniques and adherence to clean room environment practices and procedures.
- Maintain accurate records/documentation related to quality, work in progress, test results and labor (e.g. timecards, DHR’s).
- Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations.
- Work all required overtime as requested by supervisor.
Preferred Education and/or Job experience:
- High school diploma or equivalent preferred.
- Experience with medical device manufacturing is a must.
- 2-7 years of experience in medical device assembly.
- Ability to read, write, and comprehend English.
- Must have a high level of hand-eye coordination and manual dexterity to work with small plastic and metal components in a high volume manufacturing setting.
- Ability to utilize basic math skills.