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Quality Assurance Manager - Medical Device

Surrey   •  Negotiable  •  Permanent, Full time


Commitment to continuous Quality Improvement

To be fully compliant with company SOPs and MD SOPs relevant to role

Ensure procedures and systems are maintained or established to maintain the Companys 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

To undertake the formal Management Representative role and have day to day responsibility for running the MD QMS

Where required, to act as designee to the Regulatory Affairs Director when acting as the Person Responsible for Regulatory Compliance (PRRC)

Ensure procedures and systems are maintained or established to maintain the Companys compliance with ICH Good Clinical Practice; current national and international legislation; and relevant regulations, standards and guidelines

Ongoing contribution to the maintenance and development of Business Operating Procedures

Responsible for maintenance of training and familiarisation matrices, ensuring distribution and documentation of receipt of procedures amongst staff within the

Company and the virtual team as appropriate and participation in (and directing of) appropriate training programs

Liaise as necessary with third party organisations and relevant Health Authorities to represent the Company interest and resolve Quality related issues

Responsible for evaluating and reviewing third party organisations Quality Incident Reports and for preparing company Reports as necessary

Responsible for preparing investigation reports for submission to relevant authorities

Involved in the management of inspections by regulatory bodies in support of the company's accreditations, as well as those performed by customers and independent associates

Responsible for drawing up Internal and External Audit Plans (including the design of audit / inspection programs as necessary)

Oversight of the Third Party/Supplier Assessments and Reassessments

Responsible for arranging a review of Change Control data as part of the Management Review Process and communicating the status of Change Controls to the R&D Team

Responsible for arranging a review of CAPA data as part of the Management Review Process and communicating the status of CAPAs to the R&D Team

Jointly responsible for commercial product final release

Responsible for handling customer complaints, including the assessment of complaint and vigilance reportability alongside the Head of Quality, and coordinating notifications to Regulatory Bodies when acting as nominated deputy to the Regulatory Affairs Director or Head of Quality

Responsible for collating feedback data from production and post-production activities, including implementing the MD Post Market Surveillance Plan, and organising its retrospective review by the Management Review process

Responsible for maintaining non-conformance records received from applicable manufacturers

Responsible for maintaining all product field safety corrective action records as an input to the Management Review process

To provide training and guidance to all staff within the Company as appropriate

Undertake inspections of Third Parties/Suppliers

Providing assistance on day to day basis to the Research & Development team on quality matters

Maintaining a good understanding and awareness of key programmes in all company functions so as to be able to contribute to the development of overall corporate strategy and proper coordination

Knowledge, Competencies and Experience Required:

Graduate

Seasoned professional, with 5+ years professional experience in Regulatory Affairs or Quality Management Systems relating to medical devices

Good knowledge and experience of managing Quality Management Systems, e.g. ISO 13485, GCP, GMP, GDP and Regulation (EU) 2017/745 on Medical Devices (MDR)

Significant professional experience in quality management relating to pharmaceuticals

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

Strong attention to detail

Good team member, but also able to work on own initiative and self-sufficient within a small company structure

Ability to establish priorities and meet deadlines

Strong work ethic, enthusiastic and motivated

Approachable with the ability to mentor staff

Excellent computer skills, including strong working knowledge of Microsoft Office (Word, Excel, Power Point and Outlook)

  • Agency: Cpl Life Sciences
  • Contact: Sheldon Grant
  • Reference: JO-2109-477253
  • Posted: 29th September 2021
  • Expires: 27th October 2021

Cpl Life Sciences

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