Operations Supervisor I (2nd Shift)

About the role

Join Millstone Medical and be part of a high-growth company dedicated to fostering a culture of learning and growth. We provide medical services to top Orthopedic companies, focusing on sterile and non-sterile packaging of medical devices, mechanical inspection, and assembly.

Responsibilities

• Directly supervise daily operations within production and manufacturing teams.
• Lead and train team members to ensure they follow standard operating procedures (SOPs), GMP, and FDA guidelines.
• Set and monitor performance goals, providing coaching and corrective action as needed.
• Ensure all production processes comply with FDA, GMP, and other regulatory standards.
• Collaborate with the Quality Assurance (QA) team to manage inspections, audits, and corrective actions.
• Document, review, and approve production records and ensure proper adherence to documentation standards.
• Identify opportunities to improve operational efficiency and reduce production costs.
• Implement best practices and process improvements in compliance with regulatory standards.
• Monitor and report on key performance indicators (KPIs) to drive continuous improvement.
• Enforce safety protocols to maintain a safe working environment and ensure compliance with OSHA and other safety regulations.
• Identify and address potential safety hazards and participate in environmental health and safety (EHS) initiatives.
• Coordinate with supply chain and inventory teams to ensure raw materials, equipment, and resources are available to meet production schedules.
• Monitor and control inventory levels to prevent shortages or overstocking.
• Collaborate across departments including quality control, supply chain, and regulatory affairs to support smooth operations and regulatory compliance.
• Effectively communicate process changes, updates, and goals to the team.

Qualifications

• Bachelor’s degree in Operations Management or a related field (or equivalent experience).
• 3+ years of experience in a manufacturing or production environment, ideally in an FDA-regulated industry.
• Strong understanding of FDA regulations, Good Manufacturing Practices (GMP), and SOPs.
• Proven leadership skills with experience managing teams in a regulated environment.
• Excellent problem-solving, analytical, and organizational skills.
• Familiarity with safety and environmental regulations (e.g., OSHA).
• Strong communication and interpersonal skills.
• Proficiency with ERP or production management software.

Skills

The Operations Supervisor must have the ability to detect defects through visual inspection of medical devices and instruments, requiring 20/20 or corrected 20/20 vision.

Benefits

• Medical
• Dental
• Vision
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

Pay

Competitive compensation package.

Schedule

Flexible schedule to accommodate the needs of the team and the business.