Director of Operations

External applicants•Bloomfield, CT

6d•Onsite

About The Position

Millstone Medical Outsourcing, a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry is recruiting at its Testing division location in Bloomfield, CT. Millstone Medical Testing (formerly known as MycoScience) has over 30 years of expertise in medical device and pharmaceutical laboratory testing, environmental testing, and related regulatory support services. Millstone is an ISO 13485:2016 certified contract manufacturing organization operating out of an FDA-registered facility with a rigorous approach to quality that upholds Millstone’s commitment to operating under the highest quality standards. 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. We are seeking a strategic and results-driven Director of Operations to lead our Bloomfield, CT and Willington, CT medical device testing and manufacturing facilities. This role is responsible for overseeing all aspects of the day-to-day operations, driving efficiency, and ensuring compliance with regulatory standards. The Director will collaborate cross-functionally with our Quality and Commercial teams to ensure on-time delivery of services while maintaining the highest standards of quality and client satisfaction.

Requirements

Bachelor’s degree in engineering, Operations, Life Sciences, or related field required; Master’s degree or MBA preferred.
10+ years of progressive leadership experience in operations within the medical device, pharmaceutical, or diagnostics industry.
Strong understanding of laboratory operations, quality systems, and regulatory compliance.
Experience with Lean, Six Sigma, or other process improvement methodologies.
Proven success in leading cross-functional teams, managing budgets, and scaling operations.
Exceptional leadership, communication, and analytical skills.

Responsibilities

Lead and manage laboratory and production operations related to medical device testing and manufacturing (mechanical, biocompatibility, packaging, shelf-life, etc.).
Develop and execute operational strategies that align with company goals and regulatory requirements (FDA, ISO 17025, ISO 13485, etc.).
Oversee resource planning, scheduling, and capacity management to ensure timely project delivery.
Implement continuous improvement initiatives focused on throughput, cost efficiency, and quality assurance.
Monitor KPIs and operational metrics to drive accountability and performance across teams.
Ensure staff are trained, motivated, and operating in compliance with safety and quality protocols.
Collaborate with Quality Assurance and Regulatory Affairs teams to maintain compliance and prepare for audits.
Lead capital planning and process optimization initiatives for laboratory equipment and operational systems.
Serve as a key operational point of contact for clients and internal stakeholders.