Operations Supervisor I (2nd Shift)

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.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

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.

Key Responsibilities:

Supervision and Leadership:

• 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.

 

FDA Compliance and Quality Assurance:

• 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.

 

Process Optimization and Efficiency:

• 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.

 

Safety and Environmental Compliance:

• 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.

 

Inventory and Resource Management:

• 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.

 

Communication and Collaboration:

• 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.

 

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.

To learn more about Millstone Medical, please visit us online at www.millstonemedical.com.

ADDITIONAL INFORMATION:

Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.