This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Director Quality Management role to lead, motivate, and develop a team of six professionals across Quality Assurance, Supporting Operation and R&D with QA Expertise and release of products, Supplier Quality Management, QA Software Lifecylce Management, Post Market Surveillance and Document Control. The role is to further improve the structure, processes, and ways of working needed to build a scalable, efficient, and compliant Quality Management System that supports BONESUPPORT’s continued expansion. The role combines strategic leadership with hands-on involvement in daily operations.
Job Responsibility:
Lead, develop and motivate the Quality Management team
Structure, plan and lead the work within Quality Management
Provide hands-on support to the team when needed and take the lead in selected quality and change initiatives
Ensure compliance with international standards and regulatory requirements
Own and evolve the company’s Quality Management System in compliance with ISO 13485, MDR, FDA and other global regulations
Drive QMS follow –up and continuous improvement, including process optimisation and digitalisation to enable scale
Collaborate closely with R&D, Operations, Regulatory Affairs and Supply Chain to ensure quality is integrated across the entire product life cycle
Establish and monitor supplier audit programs and perform supplier audits
Safeguard quality related to contract manufacturing
Requirements:
Academic degree
Minimum 5 years of relevant experience in medical device and/or pharmaceutical industry
Proven leadership and management experience
Strong knowledge of ISO 13485, MDR, FDA other applicable global regulations
Experience building and scaling a Quality Management System
Knowledge of QA, Supplier Quality and Document Control
Experience in sterile production environments is meriting
Experience conducting supplier audits and experience with software validation is an advantage
Nice to have:
Experience in sterile production environments
Experience conducting supplier audits
Experience with software validation
What we offer:
Dynamic and stimulating workplace
Great teamwork, innovation, passion, and performance