Operations Supervisor I (2nd Shift)

Millstone Medical•Olive Branch, MS

About The Position

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work! Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices. Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance. The Operations Supervisor with FDA experience will oversee daily manufacturing, production, and operational activities in a regulated environment. This role ensures that all processes meet FDA guidelines, maintain compliance with quality standards, and adhere to safety and regulatory requirements. The Operations Supervisor will manage a team, optimize workflows, and collaborate closely with quality assurance, supply chain, and other departments to ensure that all products are manufactured efficiently and safely.

Requirements

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.
This position includes visual inspection of medical devices and instruments which requires the ability to detect defects. 20/20 or corrected 20/20 vision is required.

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 are in strict compliance with FDA, GMP, and other regulatory standards.
Collaborate with the Quality Assurance (QA) team to manage inspections, audits, and any 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.