10+ years quality or regulatory assurance experience
Iso 9001, iso 13485, fda 21 cfr part 820 compliance
Root cause analysis and capa methodologies
Cytiva is seeking a Senior Director for Quality Assurance in their Hardware Solutions business unit, focused on driving quality initiatives in the life sciences and biotechnology sectors. The role requires extensive experience in quality systems and leadership, with a strong emphasis on collaboration and strategic growth
Job Summary
The Senior Director will lead the Quality function within the Hardware Solutions business unit to drive long-term growth and business objectives.
This role requires comprehensive knowledge of medical device regulations including ISO 13485 and FDA 21 CFR Part 820 to ensure product compliance.
Candidates must possess over 10 years of people leadership experience and be willing to work on-site in Duncan, SC or Medemblik, Netherlands.
Matching Summary
Match Score: 85
Cytiva is seeking a Senior Director for Quality Assurance in their Hardware Solutions business unit, focused on driving quality initiatives in the life sciences and biotechnology sectors. The role requires extensive experience in quality systems and leadership, with a strong emphasis on collaboration and strategic growth.
Skills & Requirements
Must-have
10+ years Quality or Regulatory Assurance experience
ISO 9001, ISO 13485, FDA 21 CFR Part 820 compliance
Root cause analysis and CAPA methodologies
Medical device manufacturing process knowledge
Global leadership of quality teams
Nice-to-have
Experience in Operations, R&D, or Engineering
Danaher Business System continuous improvement knowledge
Strong stakeholder management skills
Ability to travel up to 50% internationally
Key Requirements
Bachelor's degree required
Minimum 10 years work experience in Quality/Regulatory