Clean Room Supervisor

We are seeking a dedicated and experienced Supervisor to lead our designated shift in a fast-paced manufacturing environment. The ideal candidate will ensure quality and efficiency by overseeing operations, training staff, and collaborating with various teams. This role requires strong leadership skills, a commitment to continuous improvement, and a thorough understanding of industry standards.

Responsibilities:

1. Ensure Operators on the designated shift review and sign off on Operator Instructions daily, confirming their understanding of all requirements before starting manufacturing tasks.
2. Communicate effectively with other Shift Supervisors, the Quality Manager, Production Managers, Senior Process Technicians, Junior Process Technicians, and Quality Leaders to maintain overall quality.
3. Review the department schedule for the designated shift, identify necessary inventory, and prepare for daily objectives.
4. Provide training for Medical Operators on the designated shift through written documentation and by direct example.
5. Train Medical Operators in the use and duties of IQMS and daily production responsibilities.
6. Collaborate closely with Customer Response Specialists, Planners, Quality Leaders, and Production Managers to meet and exceed customer needs.
7. Stay informed about daily reports, customer complaints, returns, or internal part failures, sharing all relevant information with production and quality teams.
8. Foster team support and participation.
9. Ensure all work is performed correctly by instructing with appropriate tools (verbal, written, or corrective methods) to align with company goals and guidelines.
10. Monitor Inventory Technicians and Medical Operators on the designated shift, developing methods to improve overall production performance and efficiency.
11. Assign Medical Operators based on manufacturing priorities.
12. Achieve performance goals (KPIs) and maintain 5S standards throughout the Clean Room for the designated shift.
13. Provide daily Clean Room production reports at the end of the shift to the leadership team.
14. Enforce company policies and procedures, taking disciplinary action as needed.
15. Understand and apply relevant ISO 13485 clauses to role responsibilities.
16. Understand and apply AS9100 clauses to role responsibilities.
17. Understand and apply ISO 14001 clauses to role responsibilities.
18. Follow ISO standards to maintain and enhance the Quality Management System.

Requirements:

• Minimum of two years of supervisory or management experience.
• Basic knowledge of quality principles.
• Understanding of measuring equipment.
• Preferred experience with CGMP/ISO 13485 standard requirements or a general understanding of these requirements.

Experience:

• At least 2 years of supervisory experience required.
• Minimum of 1 year of CGMP experience required.

If you are a motivated leader with a strong commitment to quality and team development, we invite you to apply for this position.