Director of Operations
Michael Page
Lausanne, Canton de Vaud, Suisse
vor 2 Tg.
source : Jobeo

Entreprise :

Our client is a start-up specialised in Medical Devices - Class 3, based in Lausanne.

Description du poste :

1) Operations Management

  • In collaboration with the COO, the Director of Product Development, the Project Managers and the QA Manager, supervises the production of company pipeline products.
  • Owner of following processes of the Quality Management System : Manufacturing, Transfer to Manufacturing, Suppliers Management, Purchasing, Order Handling and Delivery, Storage and Product Preservation, Equipment Qualification and Process Validation.
  • Leads local activities related to products and manufacturing technology transfers to subcontracted manufacturers.
  • Manages operations resources to effectively manufacture products in an environment that is fully compliant with GMP, ISO standards and applicable regulatory requirements.
  • Evaluates subcontractors and preparing necessary documents that define collaboration : Quality agreement, services agreement, consultancy agreement & non-disclosure agreement.
  • Ensures adequate inventories of raw materials & finished goods as well as tools, fixtures, suppliers are properly maintained.
  • Ensures adequate finish goods distribution to final users.
  • Responsible for establishing and maintaining adequate infrastructure and material resources relative to operations.
  • Evaluate overall manufacturing performance by gathering, analyzing and interpreting data and metrics.
  • Supports COO in preparing annual budget and in following-up monthly spending by providing accurate requests.
  • Prepares and finalizes Processes Validation for products towards regulatory clearance and and / or CE-Mark.
  • Perform supplier audits.
  • 2) HR Management

  • Responsible for establishing Quarterly and Annual Objectives for his direct reports. Responsible for evaluation of his direct reports on a quarterly and annual basis, providing feedback when improvement is required.
  • In collaboration with the management defines the appropriate organizational structure and develops skills by encouraging training required to achieve the company objectives.
  • Creates, maintains, and promotes a work environment of participation, open communication and teamwork.
  • Responsible for maintaining HR files up to date according to applicable procedures.
  • 3) Professional responsibility

  • All activities performed in accordance with Quality and Regulatory guidelines.
  • Maintain professional curiosity and knowledge of advancement and development in the field.
  • Willingness to acquire new knowledge specific to field through continuing education.
  • Description du profil :

  • Master degree or Engineering degree (technical school) in Mechanical Engineering, Microengineering, Biomedical Engineering or Physics with at least 5 to 7 years of experience in leading a team, leading projects, preparing budgets.
  • At least 5 years of experience in a medical device company, with direct experience of design transfer to manufacturing, manufacturing validation and external suppliers and sub-contractors management.
  • Good knowledge of EU requirements relative to development and production of active implantable devices (ISO 13485, MDR EU 2017 / 745).
  • Knowledge of US requirements relative to development and production of active implantable devices (21 CFR 820) is an asset.
  • Fluent in French and English (written and spoken).
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