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 position of Team Lead, SQA is responsible for managing the day to day activities within the Supplier Quality Assurance team ensuring Supplier approvals are maintained, audits and visits are managed and documented within OrganOx.
Manage supplier activities by means of quality audits assessments and the evaluation and introduction of new suppliers by means of quality assessment and establishing quality expectations.
Responsible for the compliance activities across all OrganOx supply chain activities (supplier management, projects, distribution), to meet the requirements of ISO 13485, CFR 820, and MDSAP.
This role will report directly to the Director, Operations Quality and will be strongly aligned with the Operations departments.
This role is expected to be onsite in our Oxford office to ensure effective control of the supply chain documentation, and collaboration with both the Operations and Quality teams.
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, and the person will be expected to complete tasks reasonably requested by the Director, Operations Quality.

SKILLS AND EXPERIENCE

• Experienced in Supplier Improvement activities
• Experienced in Problem Solving tools and techniques (8D, CAPA, FMEA, Ishikawa, etc)
• Working knowledge of performing supplier audits to ISO 13485
• Ability to travel for considerable periods of time
• Track record of managing a high performing team
• Working knowledge of GDP/GMP requirements
• Knowledge of Master Control or similar eQMS (desirable)
• Strong written and oral communication skills
• Excellent organisation and presentation skills
• Good attention to detail
• Demonstrates and promotes a collaborative working environment

QUALIFICATIONS

The Team Lead, SQA will have:

• At least 3 years working with a medical device QMS or similar regulated industry
• Lead auditor training to ISO 13485 and/or 21 CFR 820 or equivalent

Under direction from the Director, Operations Quality, the Team Lead SQA will be responsible for:

• Contributing to secure and improve the quality management system.
• Leading by example on good documentation practice and other elements of ISO 9001 and ISO 13485.
• Being a back-up for co-workers’ tasks in case of their absence.
• Clear and concise reporting in English about all activities.
• Communicating with the suppliers on complaints and returned goods. Managing and recording all return goods requests in the appropriate systems including their financial impact.
• Analyzing the rejects from manufacturing on purchased goods. Making decisions on justification of the reject (in or out specification) and communicate this to the supplier.
• Converting NCMR into a SCAR when appropriate and managing the follow-up at the supplier.
• Initiating a quality strategy for new materials and performing first article inspections.
• Performing supplier audits (initial and regular audits).
• Managing change requests to and from suppliers including end-of-life situations.
• Contributing to engineering and R&D in development projects / changes by matching supplier performance versus product, process and volume requirements.
• Monitoring supplier performance and the quality of incoming materials and components.
• Reviewing product specifications sent to suppliers on completeness and consistency.
• Performing First Article inspection(s) after changes, and when all requirements are met, releasing the goods to manufacturing.
• Authorizing the release of non-conforming supplier materials/components, based on investigations/risk assessment and rational following the NCMR procedure within the QMS.
• Produce monthly reports showing defects per month, pareto of the top issues and timing plan for addressing these.
• Produce a weekly / monthly status report for management to understand current status of activities.
• Undertake supplier development activities where required.
• Travel to suppliers to investigate quality problems, conduct audits and improvement activities.
• Initiating and leading multidisciplinary teams to implement improvements in the quality system and/or production processes.
• Training of quality system procedures to internal and external stakeholders.
• Taking a leading role in supplier management.