Careers - Quality Management System (QMS) Specialist Ability Matters
Quality Management System (QMS) Specialist Ability Matters
Ability Matters Group is a leading provider of specialist prosthetic, orthotic, and mobility services throughout the UK and Ireland. With over 25 years of experience in the industry, we work continuously to deliver the highest standard of care possible to ensure customer needs are met.
This is a newly created position for a methodical and experienced QMS Specialist to join the business, reporting into the Head of Quality. The successful candidate will play a pivotal role in helping assure continued compliance of our QMS with ISO13485 and regulatory requirements.
Are passionate about continuous improvement!
Enjoy problem solving
Have excellent attention to detail and can work with people to achieve accurate results
Have a background in medical device manufacturing
Are experienced in auditing to ISO13485
Are knowledgeable in Medical Device Risk Management
Have proven analytical skills and the ability to practically apply them
We want to hear from you!
Forming an integral part of the growing Quality Department Management, the role holder will:
Plan, perform and report internal audits in accordance with ISO13485 and company procedures.
Administer and manage site QMS CAPAs (Track, monitor, advise, review/validate, approve, and perform VoE checks)
Lead QMS CAPA meetings with relevant stakeholders
Train relevant stakeholders in Root Cause and Corrective Action
Ensure application, monitoring and reporting of Group QMS (as site level)
Prepare data for management review meetings
Attend and minute management review meetings
Manage standards, guidance and other state of the art external documentation
Plan, perform and report supplier audits
Be involved in new supplier approval process
Manage key supplier CAPA program
Help to drive continuous improvement and compliance of the QMS
The role is based full-time in Abingdon (Oxfordshire), however given the geographically dispersed operations of the Group, occasional travel will be required within the UK.
We are looking for a methodical team player who has:
Minimum of 2 years’ recent, practical experience of ISO13485
Certification as 9001/13485 auditor/lead auditor or,
Several years’ experience as QMS auditor
Experience of developing, actioning and verifying effectiveness of CAPA
Practical application of Observe, Plan, Do, Check, Act cycle (OPDCA)
Excellent interpersonal and communication skills
An attitude of continuous improvement
Exceptional attention to detail
The ability to prioritise, plan and organise efficiently and work with multiple conflicting priorities.
The role holder will be subject to a DBS check prior to commencing employment which must satisfy company standards.