CAPA Specialist

3 days ago

Oxford, Oxfordshire, United Kingdom OrganOx Full time £35,000 - £60,000 per year

ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx
metra
normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary
The CAPA Specialist will support the administration and execution of the Corrective and Preventive Action (CAPA) program. This role supports compliant and effective CAPA management in alignment with ISO 13485, FDA 21 CFR 820, and internal quality system requirements.

The CAPA Specialist will assist with monitoring CAPA activities, maintaining documentation, generating reports, and supporting cross-functional teams to ensure timely and sustainable CAPA execution. This position reports to the CAPA Manager.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

This is an onsite position in Oxford, with flexibility, to ensure effective CAPA system support.

Major Responsibilities
Under direction from the CAPA Manager, the CAPA Specialist will be responsible for:

  • Support administration of the CAPA process in accordance with regulatory and quality system requirements
  • Track CAPA status, timelines, and deliverables to support timely closure
  • Assist in verifying the effectiveness of CAPA actions and documentation compliance
  • Generate routine CAPA metrics, dashboards, and summaries for internal review
  • Assist with data analysis to identify trends and opportunities for process or system improvements
  • Support preparation activities for external audits and regulatory inspections
  • Participate in cross-functional CAPA review meetings and follow-up activities
  • Maintain CAPA files, documentation, and system data integrity in the electronic QMS
  • Support continuous improvement efforts and ensure lessons learned are documented and shared
  • Champion a team-focused, respectful approach to problem-solving and accountability
  • Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Requirements
Skills & Experience

  • Demonstrable experience in a similar role within a regulated industry (medical device, pharmaceutical, or similar) preferred
  • Experience supporting quality systems or CAPA processes preferred
  • Experience with MasterControl is an advantage, experience with other eQMS platforms beneficial
  • Strong organizational skills and attention to detail
  • Effective verbal and written communication skills
  • Ability to gather, organise, and interpret data
  • Ability to collaborate with cross-functional partners
  • Analytical mindset with interest in problem-solving and continuous improvement

Qualifications

  • Bachelor's degree in Life Science, Engineering, or related technical discipline preferred, or equivalent experience
  • Ability to travel internationally occasionally (up to 10%)

Benefits
At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.

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