Production Group Lead/ Manufacturing Lead/ Supervisor

We are seeking a motivated and detail-oriented Group Lead to support manufacturing and production operations. The ideal candidate will assist in coordinating daily production activities, ensuring quality and productivity goals are achieved while maintaining compliance with FDA regulations, Quality Management Systems (QMS), and company procedures. This role requires strong leadership, communication, troubleshooting, and continuous improvement skills in a manufacturing environment.

• Coordinate production activities in assigned work areas to ensure products are processed according to build schedules.
• Communicate work instructions and support manufacturing personnel in alignment with supervisory objectives.
• Monitor and ensure quality standards and production targets are consistently achieved.
• Conduct regular audits of processes, tooling, equipment, and personnel performance.
• Escalate equipment failures and support timely resolution of manufacturing issues.
• Track work-in-process inventory and daily production output.
• Assist in training operators and provide retraining support when necessary.
• Support priority production tasks and expedite critical manufacturing activities.
• Inspect and determine disposition of rejected components as required.
• Perform manufacturing operations as needed to support production schedules.
• Maintain awareness of industry trends, regulatory requirements, and company objectives.
• Coordinate purchase requests for equipment and services.
• Identify root causes of production issues and help implement corrective actions to prevent recurrence.
• Conduct daily meetings with manufacturing operators to improve communication and continuous improvement efforts.
• Ensure preventive maintenance (PM) and calibration records/stickers are current and compliant.
• Participate in 5S audits and weekly value stream group lead meetings.
• Perform BBSP observations and support employee training and self-service needs.
• Support company initiatives related to QMS, EMS, safety, and regulatory compliance.
• Maintain positive communication and collaboration with employees, customers, contractors, and vendors.
• Perform additional duties as assigned.

• Experience in manufacturing, production, or assembly operations.
• Leadership or team lead experience in a manufacturing environment preferred.
• Knowledge of FDA regulations, QMS, EMS, and GMP practices.
• Experience with continuous improvement methodologies such as 5S and Lean Manufacturing.
• Strong communication, organizational, and troubleshooting skills.
• Ability to train and mentor production employees.
• Familiarity with preventive maintenance and calibration processes.
• Ability to work in a fast-paced manufacturing environment and support extended shift hours.

• Experience in medical device or regulated manufacturing environments.
• Knowledge of process audits, inventory tracking, and quality inspection procedures.
• Strong problem-solving and root cause analysis skills.