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Quality Coordinator ISO 13485

Cranleigh Scientific



£30000 - £35000/annum


Posted: 13/10/2021

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A growing medical device company has an opportunity for a Quality Coordinator to join its team. You will support across a range of quality tasks and functions including maintaining and managing CAPA, change controls and audits. You must have experience of working in the medical device industry or to ISO 13485, ideally in a quality related role.

Key Duties & Responsibilities:

Commitment to continuous Quality Improvement
To be fully compliant with FMD's Medical Device (MD) SOPs and Pharma SOPs relevant to role
Coordinating role for the quality function including producing minutes and actions for monthly quality meetings
Working with the Head of Quality and Quality Manager to ensure procedures and systems are maintained or established to maintain the Company's compliance with ISO 13485 and to enable the manufacture of medical devices in accordance with current national and international legislation, relevant regulations, standards and guidelines
Supporting the Quality Manager with the ongoing contribution to the maintenance and development of Business Operating Procedures
Responsible for co-ordinating periodic training and familiarisation processes in accordance with the MD Training and Familiarisation Matrix
Providing support for inspections by regulatory bodies; notified bodies; customers; and independent associates
Scheduling and coordinating Management Review Meetings; preparing necessary information required; and ensuring review outputs are recorded and available
Supporting the implementation of External Audit and Internal Audit Plans
Coordinating, tracking and documenting MD Supplier Assessments and Reassessments
Responsible for maintaining the Change Control Register, tracking actions to completion, providing regular updates regarding CC completion to the Head of Quality and Quality Manager and retaining the completed Change Control Forms
Responsible for maintaining the CAPA Register, tracking actions to completion, providing regular updates regarding CAPA completion to the Head of Quality and Quality Manager and retaining the completed CAPA Forms
Responsible for processing MD customer complaints
Supporting the translation process for commercial product pack copy where FMD is the legal manufacturer
Supporting the collation of feedback data from production and post-production activities, including the implementation of the MD Post Market Surveillance Plan, and its retrospective review by the Management Review process
Arranging training and guidance to relevant staff within the Company as appropriate
Responsible for Document and Record Management including maintaining MD QMS reference files; quality records; records of suppliers; audit reports; and documents of external origin
Arranging and participating in regular Distributor meetings (where relevant), ensuring outputs are recorded and available and tracking actions to completion
Supporting and/or coordinating ad hoc projects as requiredKnowledge, Competencies and Experience Required:

Degree educated
Previous experience working in the medical device industry
Good knowledge and experience of Quality Management Systems, e.g. ISO 13485, ISO 9001, GCP, GMP, GDP and the EU and UK Medical Devices Regulations
Successful experience of being inspected by MHRA/Notified bodies
Excellent written and verbal communication skills
Good project management skills and capability to work with a small team of people
Demonstrable attention to detail
Good team player, but also able to show initiative and be self-sufficient within a small company structure
Ability to establish priorities and meet deadlines
Strong work ethic, enthusiastic and self -motivated
Excellent computer skills, including strong working knowledge of Microsoft Office (Word, Excel, Power Point and Outlook)

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