HEAD OF QUALITY – MEDICAL DEVICES @ DCSPL
A highly strategic leadership mandate is open with one of Africa’s rapidly growing and globally compliant medical device manufacturing organizations in Kenya. This role focuses on leading quality excellence for a high-impact healthcare manufacturing setup serving African markets with globally benchmarked standards. The position requires a candidate who can navigate complex regulatory environments while maintaining high efficiency in production processes. The successful candidate will oversee a team of over 30 members, ensuring compliance with international quality standards including ISO 13485, CE Marking, and MDSAP. The role involves managing audit leadership, GMP compliance, supplier quality, and post-market surveillance within a sterile manufacturing environment, specifically targeting syringe or disposable medical device production. You will be responsible for fostering a culture of quality and continuous improvement across the entire organization.
Key Requirements
Minimum of 10 to 15 years of experience in Quality Leadership roles.
Deep expertise in ISO 13485, ISO 9001, and ISO 14001 standards.
Proven track record with CE Marking and MDSAP Compliance procedures.
Extensive experience in Medical Device Manufacturing and Regulatory Audits.
Strong knowledge of CAPA, QMS, and ISO 14971 Risk Management.
Experience working in a Sterile Manufacturing Environment is mandatory.
Direct experience with Syringe or Disposable Medical Device Manufacturing.
Proven ability to lead and manage teams of 30 or more members.
Expertise in Supplier Quality and Manufacturing Quality Systems management.
Thorough understanding of post-market surveillance and vigilance systems.