What are the responsibilities and job description for the Medical Device Operations Manager position at AUTOCAM MEDICAL DEVICES, LLC?
Autocam Medical is a global contract manufacturer of orthopedic implants, spinal implants, precision instruments and orthopedic cutting tools. We offer a value-added approach to high-precision manufacturing, with specialties in CNC milling, turning and cutter grinding.
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We are seeking a Operations Manager with a passion to make a meaningful contribution to the medical device industry. Reporting to the General Manager, the Operations Manager will lead the continuous improvement efforts in the assigned production area through the utilization of data provided by the manufacturing systems. The Operations Manager organizes, directs, and controls the daily operations according to company goals.
Develop the continuous improvement plan and facilitate the meetings with the area team(s); prioritize team activities.
Interact with the customer directly with all issues concerning quality, delivery, and standards.
Evaluate team needs – as needed, i.e. staffing levels, equipment or tools and provide support by removing barriers for improvement and progress.
Oversee production process while ensuring teams are focused on producing product of the highest quality in a safe and effective manner.
Provide leadership and mentorship to area Team Leader(s).
Collaborate with other Value Stream Managers to review the activities of the plant and review the progress toward meeting the company goals.
Coordinate and support cross-functional teams like quality, engineering, and maintenance.
Provide production quality, delivery, or cost concerns to Plant Manager.
Coordinate with other Value Stream Managers in developing and sustaining the following :
Training and career path plan for all team members.
Process for standardizing processes and documentation.
Implement forms of visual control and documentation.
Ensure performance reviews are given to all team members.
Facilitate and manage project startup teams.
Facilitate and manage company production systems.
Other duties as assigned.
Travel : 10% - 20%
Lead, mentor and facilitate leaders in developing and planning of production and personnel.
Interpret daily, weekly, monthly, and yearly key business indicators, i.e., quality, cost, and delivery reports.
Identify improvement opportunities and utilize appropriate problem-solving tools and relevant data to continuously improve business processes.
Ability to be decisive including the development of alternative course of action based on facts and logic while considering organizational resources, values, and principles.
Effective written and oral communication with a variety of individuals both inside and outside the organization, including strong presentation skills. Express ideas and information succinctly in one-on-one and group situations.
Develop the skills and competencies of others through training and development activities.
Ability to remain calm and effective in high-stress situations.
Understands key business indicators used by the company.
Experience working with MRP systems.
Qualifications :
Preferred Bachelor’s Degree in Business or Engineering.
Minimum of 5 years of relevant experience in leadership.
Preferable to have an understanding of GMP for Medical Devices FDA 21 CFR Part 820 Quality System Regulation and ISO 13485 Medical Devices – Quality Management Systems or experience working in a regulated industry.
