Contract type: Permanent
Hours: Full Time
Location: Brainomix Head Office, Oxford (a minimum of two days per week will be required in the office)
Company background: Brainomix (www.Brainomix.com) is a spin-out company from the University of Oxford that develops and deploys imaging decision support software as a medical device. Brainomix provides solutions for multiple indications including the handling and analysis of both brain and thoracic CT imaging, with extensive international collaborations with academic, clinical and industry partners. Brainomix provides software that is prospectively used for clinical and research decision making around the world. We build world-class medical imaging software products which are sold in multiple international markets, and to accomplish this, we believe in creating a first-class working environment for a first-class team.
Summary of role: Reporting to the Head of Quality Assurance and Regulatory Affairs as part of a small but growing quality and regulatory department. The role involves ensuring compliance with applicable regulatory requirements and quality standards, maintaining and improving the QMS in support of business objectives and new or updated regulations and standards. The successful applicant will also implement the delivery of QMS outputs in support of regulatory requirements and product regulatory submissions. It is important to note that Brainomix products are developed and delivered electrically as a software device. The company do not currently manufacturer any physical products.
- Proactively and independently leading and carrying out day to day quality management activities.
- Managing and delivering QMS improvement projects supporting company objectives.
- Promoting and assisting process development and continuous improvement for all areas of the company.
As part of the role, you will:
- Assist the Head of QA/RA in ensuring conformance to all regulatory and quality requirements applicable to Brainomix.
- Support departmental heads in the identification and implementation of improvements of procedures and determining process performance indicators Identify and deliver process and system changes to improve the effectiveness and compliance of the Quality Management System.
- Interpret and implement all quality assurance standards and procedures
- Delivering and overseeing the internal training process to staff at all levels, including determination of QMS training requirements
- Lead supplier evaluation and approval activities.
- Coordinate and support audits conducted by external providers as well as developing and managing internal audit processes, carrying out and scheduling internal audits with a team.
- Evaluate audit findings and non-conformances and manage the implementation of corrective actions.
- Support project teams to meet design control requirements, deliverables relating to product safety, usability, risk management, compliance and product performance.
- Assist with deviations, defect handling and change control processes.
- Lead in the identification and management of process risks and proactively escalate issues and risks to Head of QA/RA
- Provide support for regulatory activities including product and company registrations as well as assist with the preparation of product regulatory clearance submissions
- Liaise with notified bodies, certification bodies, economic operators and Brainomix partners.
- Pursue learning and self-development and sharing of knowledge with others.
- Participate in other duties as required.
Qualifications, skills and Experience:
- Batchelors degree
- Detailed understanding of ISO 13485 and ISO 14971 requirements and experience of practical application within a QMS.
- Detailed knowledge of MDD 93/42/EEC and Medical Device Regulation 2017/745 QMS requirements
- ISO 13485 Auditing Certification and Lead Auditor experience
- Knowledge and experience of Root cause analysis techniques, CAPA investigation and resolution.
- Experience of developing and improving processes and procedures.
- Knowledge and experience with Risk Management tools and techniques
- Knowledge and experience of design control and validation activities
- Good practical knowledge of Microsoft Outlook, Word, Excel and PowerPoint
- Excellent written and verbal Communication skills
- Ability to manage multiple tasks concurrently and to prioritise effectively
- Strong organization and problem-solving
- Exceptional attention to detail
- Experience and knowledge of Software as a Medical Device.
- Understanding and practical application of IEC 62304
- Understanding and practical application of IEC 62366
- Understanding and practical application of ISO 27001
- Experience of independently leading external audit activities
- Experience of managing complaints investigations.
- Process design and management techniques.
- Experience of collating and using Key Performance indicator data to drive process improvements
To apply for the role please email a copy of your covering letter and CV to firstname.lastname@example.org