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Director Quality Management

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Cerament (Bonesupport)

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Location:
Sweden , Lund

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

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

Additional Information:

Job Posted:
February 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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