Quality & Regulatory Manager
Location
Oxford, Oxfordshire | United Kingdom
Job description
Quality Manager
Application Deadline: 21 February 2024
Department: Q & RA
Employment Type: Full Time
Location: Oxford
Reporting To: Quality & Regulatory Director
Description
Want to be part of a team transforming healthcare?
We are looking for a talented Quality & Regulatory Manager to join our team. Quality is at the heart of our company, and you will work closely with the Q&R Director to plan, direct coordinate, and improve the quality assurance activities associated with Adaptix’s electronic quality management systems to ensure compliance with internal and external quality and regulatory requirements.
The Company
Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much more expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile flat-panel X-ray systems that can be brought to patients giving low-cost, low-dose imaging.
Candidate Profile As our ideal candidate you will have a BSc degree as a minimum, or equivalent experience in a science-related role.
Key Responsibilities
Main duties and responsibilities:
- Establishing and maintaining the company's quality procedures, standards and specifications to ensure satisfaction of Company required standards in collaboration with the Q&R Director. This includes compliance with ISO 13485:2016 and any other ISO or quality-related regulations targeted by the company
- Facilitating and leading change management initiatives and monitoring their implementation
- Setting standards for quality across the company and ensuring compliance within the company, escalating any issues to the appropriate person
- Working with the Q&R Director to ensure that processes meet international standards once products transfer into manufacturing or production
- Working closely with all employees to ensure that there is a focus on continuous improvement and maintaining a strong quality culture throughout the company
- Setting up and maintaining best practice controls and documentation procedures to ensure compliance with international and national standards
- Helping to develop and improve the processes by which the company complies with regulatory requirements
- Handling customer complaints, investigations and provide reports and recommendations
- Monitoring performance by gathering relevant data (e.g. by way of internal audits, corrective and preventative actions) and producing reports for quality meetings, management review or as requested by the Board
- Leading implementation, administration and improvement activities associated with Adaptix’s LMS, covering internal and external training, inductions, training assignment creation, and maintaining / tracking course revisions/history
Skills, Knowledge and Expertise
Skills:
- Excellent communication skills, including the ability to work with others to manage change in an environment where there are multiple stakeholders
- Shares specialised knowledge, skills and learning from experience across different situations and contexts effectively
- Proactive, self-motivated and driven to achieve results
- Attention to detail with the focus and tenacity to see tasks through to completion
- Well organised with the ability to prioritise and de-prioritise effectively to manage competing demands
- Ability to deliver results and achieve business goals in a changing environment
- Aptitude for problem solving, analysis, organisation and planning..
- Ability to remain calm and self-controlled, and to maintain a high level of performance when facing change, pressure or uncertainty
- Gains the trust of others by providing expert information and advice in a professional and credible manner and inspires others to do the same
Experience:
- Proven track record of achieving and maintaining ISO quality accreditation and rolling this out within a company (ISO 13485, ISO 14001, ISO 27001)
- Experience of using electronic QMS management tools including LMS
- Experience of working in quality management roles in science-based R&D or manufacturing organisations
Apply Now
This is a permanent full-time role based at our commercial site in Eynsham, but occasionally also at our R&D offices in Begbroke Science Park, Oxfordshire. Compensation is competitive and commensurate with experience.
Please note the closing date for applications, however, should we find a suitable candidate before this date, the position may be filled earlier. Please note that we are unable to provide sponsorship for visa applications for this role.
If you feel that you would excel in this role we would be delighted to hear from you!
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