Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.

Summary:
The Vice President of Operations is a key member of the Company’s Senior Leadership team.  This position is responsible for overseeing and optimizing the company’s operational functions to ensue efficient production, quality, and distribution of medical devices.  This role requires a combination of strategic thinking, leadership, and hands-on management to drive excellence in operations.

 Responsibilities:

• Collaborate with the executive team to set the strategic direction of the company. Develop and execute operational strategies to support and grow productivity, quality, and fiscal corporate objectives.
• Implement best practices to optimize efficiency and reduce cost. Mitigate risks and develop contingency plans.
• Drive innovation in manufacturing methods to improve product quality and production efficiency. Collaborate with engineering staff to develop capital expenditure strategies which improve efficiencies, foster cost savings, and enhance revenue.
• Champion continuous improvement of business systems and processes to enhance efficiency and scalability.
• Build and lead an operations team, providing mentorship, coaching, team-building, and performance management. Foster a culture of collaboration, accountability, and continuous improvement for a high-performance, results-oriented work culture.
• Develop departmental budgets and allocate resource effectively. Drive initiatives to improve operational profitability and reduce waste.
• Establish and utilize key performance indicators in the areas of safety, quality, delivery, cost, capacity, and staff productivity. Use data-driven insights to inform strategic decisions and drive operational excellence.
• Ensure compliance with health and safety regulations, creating a safe working environment for all employees.
• Maintain rigorous standards in compliance with relevant regulatory requirements (e.g. FDA, EU, ISO).
• Oversee the supply chain, including production planning, procurement, inventory management, and supplier relationships. Utilize ERP, PLM, and MES tools to optimize capacity planning, material movement, manufacturing floor management, and reporting.
• Collaborate with Sales and Marketing, R&D, and Quality to support new product development efforts from a manufacturing and sustaining engineering perspective. Provide cross-functional leadership on a R&D Steering Committee.
• Optimize warehousing operations to ensure on-time delivery of products to customers.
• Oversee maintenance activities to ensure equipment reliability and facility compliance. Plan for facility expansion or improvement projects to support company growth.

Requirements:

• Bachelor of Science in a relevant field (e.g. Engineering or Operations Management). MBA or MS in relevant discipline preferred.
• 15+ years of proven leadership experience in role of progressive responsibility within the medical device industry or related fields.
• Excellent working knowledge of the FDA Quality System Regulations, EU Medical Device Regulations, ISO 13485, and ISO 14971.
• Excellent leadership, interpersonal, and negotiation skills.
• Demonstrated ability to drive change and lead continuous improvement initiatives that enhance performance and scalability.
• Significant experience with computerized manufacturing management systems, methods, and an in-depth knowledge of computer-based ERP systems, controls, and capabilities.
• Demonstrated leadership utilizing process improvement strategies such as Lean, Six Sigma, or other TQM processes.
• Strong financial acumen

Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/dental/vision, and other excellent benefits

An Equal Opportunity Employer