Quality Assurance Director - Medical Device

Job content

• To be the Quality Management representative for the site as well as the Person Responsible for Regulatory Compliance
• Establishes and maintains quality assurance programs, procedures and controls including quality control, quality engineering, product release, CAPA and non-conformances, document control, complaint investigation,
• Ensures that performance and quality of products conforms to established company and regulatory standards
• Develops and implements the company quality assurance strategies
• Acts as advisor to subordinate supervisors or staff to help meet established schedules or resolve technical or operational problems
• Submits and administer budget schedules and performance standards
• Oversees quality assurance auditing of production areas and systems
• Reviews reports findings and makes recommendations for corrective actions
• Provides support to the Supplier Quality assurance team
• Collaborates with Plant Manager and site Leadership team to maximize product reliability and minimize cost
• Organizes the department to support QA activities. Ensures that goals and objectives are set and followed for every QA employee in accordance with companies Governance & Oversight’s.
• Participate and ensure that investigations and other actions are done in due time to support operations plan
• Ensure Lean management activities in QA department
• Ensure that all assigned personnel have the education, training and experience in order to carry out all job duties and responsibilities
• Ensures the implementation of world-class quality programs to support entire product life cycle with focus on business results including prevention and detection of defects at earliest phase
• Escalate any product /resources issues to site and QA management
• Reporting as per group guidelines (Tier 3, …)
• Take in charge project as requested by management
• Propose and if approved put in place any improvement for the organization

• Master Degree in Engineering, Life Science or a related technical discipline.
• At least 10 years of professional work experience within a quality assurance or compliance audit environment
• Demonstrated experience and track record in people leadership and in conducting and/or leading regulatory assessments in an international, global context, in a regulated environment
• Prior experience of External Regulatory and/or Notified Body Inspections (e.g. FDA)
• Strong management skills
• Strong communication, organizational, negotiation and interpersonal skills
• Strong analytical problem-solving skills.
• The ability to collaborate with all levels of management across multiple sites and functions
• Fluent in French and English
• Strong knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC,2017 745, 21 CFR part 820, EUMDR, Canadian, Japanese, Australian, Brazilian regulation…
• Result driven, Proactive