Production Supervisor - Medical

Purpose:  The Manufacturing Supervisor – Medical is responsible for overseeing daily production operations within the medical manufacturing area to ensure safe, efficient, and compliant manufacturing of quality products. This role provides direct supervision to production employees, supports workflow execution, and ensures adherence to cGMP, ISO 13485, and internal quality standards. The Supervisor serves as a hands-on leader on the production floor, focusing on execution of schedules, employee performance, and continuous improvement within assigned areas or shifts

Essential Duties and Responsibilities:

• Production Oversight:  Supervise daily die-cutting and medical manufacturing operations to meet production schedules, quality standards, and on-time delivery requirements. Monitor workflow, staffing levels, and resource utilization within assigned area or shift. Address routine production issues and escalate complex matters to the Manufacturing Manager.
• Team Leadership:  Directly supervise machine operators, technicians, and production personnel. Train, coach, and develop employees to ensure performance expectations are met. Conduct performance evaluations, provide feedback, and administer corrective action as needed. Promote teamwork, accountability, and a culture of continuous improvement.
• Quality & Compliance:  Ensure production activities comply with cGMP, ISO 13485, FDA regulations, and company procedures. Verify accurate completion of batch records and manufacturing documentation. Support internal and external audits as required. Reinforce lot traceability and documentation accuracy
• Process Improvement: Identify and implement process improvements to enhance productivity, reduce waste, and improve product quality. Utilize lean manufacturing and Six Sigma principles.
• Equipment Management: Oversee the maintenance and repair of die-cutting machinery, fixtures, and dies. Collaborate with maintenance staff to minimize downtime and ensure equipment is properly calibrated and maintained.
• Inventory & Materials: Coordinate with supply chain and logistics teams to manage raw material inventory and finished goods. Ensure materials are properly tracked and handled to maintain lot traceability.
• Safety: Champion a safety-first culture. Ensure all employees follow safety protocols and that the manufacturing floor is compliant with all health and safety regulations

Education and Experience:

• Associate’s or Bachelor’s Degree in Business, Engineering, or related field preferred.
• Minimum of 3–5 years of experience in a manufacturing environment.
• At least 1–3 years of supervisory experience preferred.
• Experience in medical device manufacturing and familiarity with die-cutting processes preferred.

Job Knowledge, Skills and Abilities:

• Proven leadership and people management skills.
• In-depth knowledge of cGMP, ISO 13485, and FDA regulations.
• Strong problem-solving and analytical abilities.
• Excellent communication and interpersonal skills.
• Proficiency with ERP/MRP systems and Microsoft Office Suite

Supervisory Responsibilities:

•      Yes.

Physical Demands:

• Light to moderate physical effort required on a constant basis
• Must be able to lift up to 50 pounds
• Required to sit, stand, bend, reach and move about the facility for an entire shift

Personal Protective Equipment:

• Protective equipment could include masks, hairnets, lab coats, shoe covers required for Class 7 or Class 8 clean room manufacturing.

Work Schedule:

• Normal Schedule – 8 am to 5 pm; Monday thru Friday; May vary with business needs.

Work Environment:

• Work performed in a plant/production environment
• Must be able to work as part of a team or independently with limited supervision