Operates department machine and equipment according to Standard Operating Procedures (SOPs), Machine Setup (MS), Manufacturing Procedure (MP) instructions, job orders, specifications, engineering drawings, and job order special instructions. Maintains quality system requirements for medical device manufacturer according to ISO 13485 and FDA 21 CFR 820.
1. Adheres to Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP)
2. Reads work order and/or engineering drawings and manufacturing specifications to produce product as required.
3. Communicates with co-workers and supervisors to receive instructions and coordinate activities along with job order performance.
4. Visually inspects or measures in-process and finished product for specified quality attributes
5. Completes work orders and other related Device History Record (DHR) paperwork as required
6. Supports 5S, Lean Six Sigma, and continuous improvement projects within the department and facility to support quality objectives, along with customer and business needs.
7. Other duties may be assigned in different areas of the department, employee, must be able to multi task.
8. Employee will be trained to operate department machinery, must meet productivity standards and maintain good quality of work produced.
9. Will need to be punctual and report to work station on time. Good attendance is a requirement.
10. Practice good housekeeping and be well organized.
11. Follow rules of conduct, dress code, PPE (personal protective equipment) must be practiced always.
• Employee must meet quality standards of productivity set by the company
• Occasional decision making regarding quality of product proceed
• Will need to be able to work in different areas of the dept. and learn new job skills
• Will need to be able to work with others in group setting
•Will need tot be able to lift up to 30 lbs
• Will need to have understanding of blueprints and schematics
• Will be operating with a micrometers and calipers
• Will need to be confident with occasionally making own decisions.