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Head manufacturing with leading medical device MNC
- An opportunity to lead the manufacturing and operations function for an MNC
- The chance to grow with a new entrant in the medical devices space
About Our Client
Our client is a Swiss MNC in the medical device space. They are over 60 years old and employ over 3500 people. They operate in a niche and fast growing segment within the Medical Devices space and their products are available in over 70 countries. They have recently decided to invest in India and are looking for a team to lead these efforts.
- Manage day-to-day manufacturing operations, including optimizing work flows, material supply, equipment efficiency, implementing a compliant and comprehensive quality management and the preparation of new product launches. These tasks are expected to be carried out within an approved budget under constant monitoring of the cost development.
- Translate overall build plan requirements into specific inventory levels taking into consideration yield, cycle time, and resource availability. Devise, implement and manage a system for production scheduling that maximizes productivity and throughput. Develop, monitor and report key performance indicators relating to the overall manufacturing unit to ensure that the company's processes and products are in compliance with the medical device regulations.
- Ensuring that safety regulations and standards are met and the work environment is safe, well maintained and clean at all times.
- Plan and administer procedures and budgets in alignment with Corporate requirements.
- Prepare a budget proposal for review and final approval at headquarters. Control capital expenditures and operating expenses regularly.
- Manage and steer manufacturing operations to ensure full compliance towards regulatory standards, processes and procedures and alignment with standards.
- Develop schedules and manpower requirements for the manufacturing plant. Select, develop and evaluate personnel to ensure the efficient operation of the plant.
- Analysing of in-process control and final inspection dates, issue reports and make technical recommendations.
- Assist in Risk Management activities and ensure compliance to standards and regulations.
- Lead preparation for the conduct of regulatory agency inspections.
The Successful Applicant
- Bachelor's degree in a scientific or engineering discipline with minimum 10 - 15 years of experience in a similar position in the medical device industry
- Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulatory documents
- Understanding of sterilization validation and material biocompatibility requirements
- Proven experience in quality management (QMS) and regulatory affairs for medical devices. Knowledge of Good Manufacturing Practices (GMP) and applicable Quality Management System Standards
- Proficiency in MS Office is a must. Experience in SAP experience will be an added advantage
- Proven track record of success facilitating progressive organizational change and development within a growing organization.
- Experience in working in a global matrix organisation. Candidates with international exposure and/or assignments are a plus
- Excellent verbal and written communication skills in English and local languages
What's on Offer
The Head of Operations is an experienced person within the medical device industry with extensive knowledge performing the function within the healthcare sector. The incumbent has the ability to take strategic direction and to establish efficient and compliant processes throughout the organization. He has strong communication at all levels. This position is responsible for directing the overall development and implementation of activities in the production area(s) to meet production goals, quality, and cost objectives. A particular emphasis will be required to upgrade the plant in regards to quality management, technology and manufacturing processes as well as inspection and control procedures.
The ideal candidate is a change agent who is willing to play an active role in a change environment and supports the ongoing implementation and further transformation of a privately owned business into a subsidiary of the group. Preferably the candidate has worked in a company with a similar business model (medical manufacturing industry with direct sales model and consignee sales, international footprint, matrix organization, etc. ).
The position is based in India, Mumbai and reports into the Global Research, Development and Operations Organization (the final reporting line within RD&O still needs to be determined).