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Lead Internal Auditor

Reference ID : NHCL01
Category :
  • General Manufacturing
  • Medical Devices
  • Pharma / Biotech
  • Science
Date Posted : Dec 21, 2018
Job Location
  • Munster
- Limerick
Experience : 8+ Yrs
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
Lead Internal Auditor required for leading Munster based Medical Device multinational

Principal Responsibilities

Quality Auditor

We are actively seeking to recruit a Quality Systems Engineer to lead the Internal Audit System within a leading Munster based medical Device multinational.  The successful candidate will also assist in the implementation and improvement of the QMS.

Key Duties:

  • Maintain the Internal Audit System acting as the Quality Auditor with a team of Internal Auditors.
  • Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations.
  • Ability to implement and improve a QMS
  • Organise and manage site preparation for Regulatory and Corporate Audits.
  • Manage Audit back rooms for Regulatory and Corporate Audits.
  • Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times.
  • Conduct Supplier audits.
  • Ability to lead and drive assigned Process Improvements essential.
  • Prepare, implement and analyse key Quality Systems related documentation.
  • Provide input and support to the CAPA program.
  • Provide training on the Quality Manual and other key Quality Systems procedures.
  • Prepare Management Review presentations as appropriate.
  • Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
  • Provide inputs to KPI’s and Management Review.

Qualifications & Requirements

Qualifications / Requirements:

  • Degree in Quality, Science or Engineering. 
  • A minimum of 4 years of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
  • Qualified and experienced Lead Auditor, preferably within the Medical Device Industry.
  • Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
  • The ability to challenge thinking/opinion/actions in light of ensuring Quality Systems is adhered to.
  • High attention to detail in all aspects of the role.
  • Excellent organisational skills.
  • Proven problem-solving skills.
  • High self-motivation.
  • Good working knowledge of Microsoft Office.
  • Willingness and availability to travel on company business.


For more information contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie

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