Operations Supervisor/Manager

Job Summary:

The Operations leader is responsible for the production of high-quality products while minimizing waste, both in material and time, by using the least amount of labor and material to create a given product and to keep the production cycle moving while maintaining a consistently high quality of work in compliance with medical device standards. The Operations leader manages all aspects of the production environment to include; material planning, assembly, packaging, & distribution. They will lead changes in operations from a process development and manufacturing engineering perspective ensuring best practices are adhered to and that metrics on safety, quality, delivery and cost are continually improved. The role also manages after sales support to include service and repair of medical devices.

Responsibilities
(Specific tasks, duties, essential functions of the job)

• Hire, manage and develop associates for the day-to-day execution in a manufacturing and shipping environment.
• Responsible for end-to-end material ordering and transactional information flow throughout the factory; from suppliers thru production, shipping, and to customers, including inventory accuracy.
• Negotiate with vendors for materials, supplies, equipment, and services used by the Company, where contract pricing is not established.
• Coordinate the transition of raw material during the launch of new products and engineering change orders.
• Responsible for S&OP attainment and therefore creates and maintains plans for raw materials/WIP/FG inventory levels to support customer service.
• Integrates a LEAN/CI approach to the manufacturing strategy which encompasses lean product development, lean manufacturing principles and optimization of process/product flow utilizing tools such as VSM, Standard Work, TPI, KanBan, 3P, VRK, PSP etc. And Daily Management for KPI reporting.
• Identify trends in quality and process variations as part of establishing a monitoring system that drives root cause analysis and problem solving with A3 thinking.
• Oversight and management of manufacturing documentation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations, and equipment calibration / maintenance.
• Supports design changes through document control and implementation.
• Responsible for manufacturing process validations including IQ/OQ/PQ/SQ.
• Work with different vendors, departments and people to coordinate facility maintenance and equipment repairs and ensure that all work complies with the quality management system and applicable medical device standards.
• Be able to prioritize in a fast-paced environment.
• Maintain and operate within budgetary guidelines. Requests quotes for goods and services and manage labor cost.
• Optimization of employee engagement.
• Supporting internal/external audits and Interfacing with agencies, employees, and counsel on behalf of the business when required.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.

Knowledge, Skills, and Abilities

• Must have knowledge or desire to implement and utilize lean manufacturing principles including waste reduction, continuous improvement, standard work, and problem solving
• Knowledge of FDA GMP and ISO quality systems.
• Experience working in an FDA and ISO 13485 environment.
• Attention to detail and follow through required.
• Must have a passion for product quality and excellence.
• Detail oriented with attention to product quality.
• Self-motivating and capable of self-direction.
• Good attention to detail and accurate and complete documentation.
• Ability to lead and manage other associates and projects.
• Vision and desire to grow the department and its capabilities.
• Must have strong work ethic.
• Excellent oral and written communication skills required.
• Analytical & problem-solving skills & ability to multi-task.
• Solutions-oriented problem solver.
• Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel, effective conflict resolution

Qualifications
(Experience and Education)

• Bachelor's degree in Mechanical, Industrial Engineering or related technical discipline required.
• 5 years management experience or a strong aptitude to develop leadership behavior.
• 5 years of experience in manufacturing and/or assembly, required
• 5 year of medical device experience in a regulated environment required.
• Advance knowledge/proficiency in Microsoft Office and Cad software (Solidworks), MRP/ERP systems (Oracle) required.
• Knowledge/proficiency ISO 13485, required.
• Language Requirements: Fluency in English and French is required. Candidates must be able to read, write, and communicate professionally in both languages.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Contractor, consulting, freelance, fixed-term contract