Production Specialist
We are the people who give possibilities purpose
Responsibilities
- Perform medical-device assembly, processing, inspection, testing, packaging, and/or labeling according to approved procedures and work instructions.
- Work within an ISO-classified cleanroom while following gowning, hygiene, material-handling, and contamination-control requirements.
- Follow applicable GMP requirements, company procedures, and the Quality Management System, including requirements established under
21 CFR Part 820 / FDA Quality Management System Regulation (QMSR)
ISO 13485
, as applicable.
- Complete Device History Records (DHRs), travelers, batch records, inspection records, and other controlled documentation accurately and contemporaneously.
- Verify materials, components, equipment, tooling, and documentation before beginning manufacturing operations.
- Perform in-process inspections and measurements using approved inspection equipment and acceptance criteria.
- Identify and promptly report nonconforming materials, products, equipment conditions, documentation discrepancies, or process deviations.
- Maintain traceability and proper identification and segregation of materials and products throughout the manufacturing process.
- Operate production equipment and tooling according to approved procedures and applicable safety requirements.
- Maintain clean and organized work areas in accordance with cleanroom and 5S requirements.
- Participate in line clearance, cleaning, environmental-control, and changeover activities as required.
- Assist with troubleshooting manufacturing issues and communicate observations that may affect product quality or production efficiency.
- Support process improvements, validation activities, engineering builds, training, and implementation of new or revised manufacturing processes as assigned.
- Demonstrate proficiency in assigned manufacturing processes and, when qualified, assist with training other production personnel.
- Meet established production and quality expectations without compromising product quality, documentation integrity, or regulatory compliance.
Minimum Requirement
- High School Diploma or GED
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
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