Production Lead

Job Title: Production Lead

Location: Scarborough, ME

Shift: Grave Shift (10:00 PM – 6:30 AM, Sunday – Thursday)

Pay Rate: $33.93 / hr

Position Overview

We are seeking a proactive Production Lead to oversee and coordinate grave-shift production activities within our Scarborough, ME manufacturing facility. In this role, you will lead daily operator communications, ensure production schedules and quality goals are met, perform quality and 5S audits, provide hands-on operator training, and maintain compliance with FDA and QMS regulatory standards

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Key Responsibilities

• Coordinate daily production workflow, assign tasks, and communicate work instructions to operators to meet build schedules and quality metrics.
• Perform routine process, quality performance, 5S, and BBSP safety audits; ensure PM and calibration stickers are up to date on all tooling and equipment.
• Provide direct training and re-training to area operators, offering timely feedback on defects and quality improvements.
• Track work-in-process (WIP) inventory, record daily output quantities, and expedite priority products through assigned work areas.
• Troubleshoot operational issues, identify root causes to prevent recurrence, and report equipment failures to supervision/maintenance.
• Inspect and determine proper disposition of rejected components per standard operating procedures.
• Hold daily continuous improvement meetings with operators and participate in weekly cross-functional group lead meetings.
• Assist operators with Employee Self-Service needs and step in to perform direct manufacturing operations when necessary to support production goals.
• Maintain strict compliance with FDA regulations, Quality Management Systems (QMS), Environmental Management Systems (EMS), and internal safety policies.

Qualifications & Requirements:

• Prior leadership, team lead, or senior operator experience in a manufacturing environment (medical device or FDA-regulated industry preferred).
• Strong understanding of continuous improvement practices, 5S, quality auditing, and equipment PM/calibration processes.
• Practical experience in manufacturing assembly, WIP tracking, and component inspection/disposition.
• Proven ability to train, mentor, and effectively communicate technical instructions to production personnel.
• Excellent problem-solving, organizational, and interpersonal skills.