Quality Management Systems Specialist -Medical Devices

Job Ref: NB100214

Industry Sector: Technical & Engineering

Location: QMS Specialist -Medical Devices

Type: Permanent

Salary: DOE

Contact: Contact Us

Job Description

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QMS Specialist

Purpose of Role:

The QMS Specialist will report to the QCRA Manager across the Healthcare Group to support our Quality Management System requirements.  This role will require occasional travel between offices in Dublin, Belfast, and UK .The primary purpose of the role is to be responsible for the management of QMS requirements ensuring you meet and exceed our clients contractual and regulatory obligations, providing best practice in QMS. The Quality Management System needs to fulfil the requirements of a QMS for ISO 9001:2015, Wholesale Distributors Authorisation (WDA) from the HPRA, GDP requirements for EUDR for Medical Device Distribution as well as LSAS (Labour Standards).

Principle Duties & Responsibilities:

  • Internal Audits to be scheduled and completed for the year for all sites and standards.
  • CAPA including Root Cause Analysis – review and follow up of actions and their effectiveness
  • Annual checks to be completed – all records required to be documented
  • Management review – by business unit, and by standard
  • Monthly/quarterly updates and all documentation to be filed
  • Document Control Schedule – SOPs / Policies / Flows / Forms – register and management of same including version control for SOPs, index register, go live and communicate.
  • Change Control – management of Change Control Process, document each request and follow up for closeout
  • Risk assessment and mitigation actions documented and followed up with relevant Managers
  • Monthly/quarterly metrics to report on progress on each functional area
  • Quarterly Feedback review metrics, by business unit– documents actions and close out
  • Ensure records are maintained of Temperature and Humidity monitoring requirements
  • Customer Satisfaction – manage the expectations of and requirements for a QMS for both internal and external stakeholders
  • Preparation for and involvement in external audits
  • Responsible for the introduction of new /amended SOPs into QMS working closely with the Projects Department
  • Role Requirements:

    The successful candidate will be hardworking and enthusiastic with an interest in Quality Compliance, possibly pursuing further training in this area.  They should have the following skills and qualifications:

  • Third level qualification required in Quality, Science, or Business
  • Minimum 3 years’ experience directly involved in a Quality Role within a well-developed QMS and a regulatory environment
  • Strong communication, interpersonal and prioritizing skills
  • Results / Output driven with the ability to drive a Quality agenda
  • Influence change across the organization, sharing a vision for Quality
  • Good time management
  • Keen attention to detail
  • Good planning & organizing skills
  • Ability to work effectively and cooperatively with others – stakeholder management
  • A good work ethic with a positive can-do attitude and approach to work
  • Ability to work on their own initiative and equally as part of a team
  • Full Clean Driving License required

Interested? Email your CV Now Nichola.obrien@cordantpeople.ie

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