Production Manager
Role Focus:
Production Manager is responsible for the site manufacturing activities and to guarantee quality, safety, conformity, yield, productivity and timely delivery of the products manufactured on Natec site.
Key Activities & Accountabilities
The job holder shall manage manufacturing cells in compliance with Quality Management System and applicable good manufacturing practices (GMP) and regulations.
Especially, the job holder is responsible for ensuring an overall control on manufacturing operations and efficiency mainly by:
Management:

• Managing and motivating manufacturing staff by deploying strong leadership qualities.
• Providing sufficient and relevant information, instructions and training to all reports to ensure competency levels are reached and skills matrices and training records are kept up to date.
• Promoting an atmosphere of open, appropriate and accurate communication in order to enhance the company culture and contribute to the company’s global efficiency.
• Preparing reporting (weekly/monthly), KPI’s, in accordance with Management instructions and needs.
• Displaying and offering commentary on result’s and KPI's to production employees.
• Ensuring a close monitoring of the operating budget so that costs are always kept under control.
• Ensuring that health, safety and environmental policies are followed as per QA, FDA 21 CFR820 and ISO 13485 requirements.

Quality:

• Ensuring that up-to-date policies, practices and procedures are implemented and followed by the department.
• Maintaining environment and equipment in good conditions by first maintenance level and cleaning.
• Ensuring the use of compliant products and equipment in the manufacturing field, together with correct ergonomics of the manufacturing work stations.
• Ensuring high housekeeping standards are set and maintained at all times.
• Leading assigned NC or CAPA resolution.
• Supporting QA during investigations (complaints/NC).
• Being the key contact during audits and inspections with regard to manufacturing sections.

Performance:

• Planning and scheduling production slots, organizing Clean Room operators and allocation of their tasks, according to working time and in alignment with planned and unplanned absences, to ensure the weekly manufacturing targets.
• Making sure that products are produced and dispatched on time to meet internal customer requirements.
• Ensuring a tight control of consumption of raw material, and inventory level to reduce working capital.
• Being responsible for setting up, monitoring and maintaining the process execution.
• Ensuring the organization of periodic physical inventory controls.
• Keeping a close control of waste streams and ensuring that the correct packaging and labelling are used.

Improvement:

• Monitoring the production processes and propose production changes as required (priorities) in alignment with planning requirements in collaboration with the Engineering & Methods Manager.
• Supporting new projects introduction during process transfer in collaboration with the Engineering & Methods Manager.
• Continuously looking to increasing productivity and managing yields and propose change in collaboration with the Engineering & Methods Manager.
• Investigating low performances and propose actions and improvement in collaboration with the Engineering & Methods Manager (change control request)
• Managing projects assigned to Manufacturing.
• Ensuring cross collaboration with other facilities (cross check audit, quality walk, Gemba Walk, etc.)

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Authorities
Has authority to:

• Check and release the batch records and give them for Quality review.
• Decide on immediate actions linked to deviation sheets in agreement with the Quality Department.
• Validate the trainings and approve vacation for his staff.
• Organize the working time of his department.
• Financially engage the company by signing purchase orders or contracts, inside his authorized scope and in accordance with the applicable corporate policies.

Does not have authority to:
Does not have authority to:

• Modify the manufacturing processes, change raw material supply and methods of environment controls.
• Release finished products.

Qualifications & Experience

• Engineer or Technician by training, in chemistry, biology or mechanics with knowledge of chemistry and processes acquired through a significant experience.
• Proven track record of deploying a range of tools/approaches to improve operational performance & Continuous improvement (e.g. value stream mapping, 5S, standard work, visual management, Kaizen, lean principles)
• Proved successful experience in a production unit, ideally acquired in the field of medical devices or similar.
• Good knowledge of the standards ISO9001 / ISO13485 / CFR 21 part 820 and of the Good Manufacturing Practices (GMP).
• Rational, open, dynamic, proactive and organized spirit, with good analytical skills.
• Good interpersonal skills allowing a participative and leader behaviour, with an appropriate level of authority.
• Advanced knowledge of basic software tools such as Microsoft Office.
• Fluency in French and English.