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QA/RA Supervisor (Medical Device)

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 14/09/2017
  • Job reference: J374057A

QA/RA Supervisor (Medical Device)

Location: South Ireland

Job Type: Perm

Salary: Neg.

Description

The QA/RA Supervisor is responsible for the supervision of development, maintenance, and distribution of quality documents within the Quality Management System.

The QA/RA Supervisor is responsible for:

Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System. This will cover

  • Management of the PMR system.
  • Change Control Process.
  • Documentation Control system for the QMS.

Supervision of the Regulatory department to:

Ensure continuous compliance with the following:

  • FDA Quality System Regulation 21 CFR 820 (QSR)
  • Medical Device Directive
  • Health Canada Medical Device Regulations
  • ISO13485 Medical Device Quality Management System
  • ISO14971
  • Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards
  • Any other applicable market regulation

Leading the preparation and direct all activities for:

  • FDA inspections,
  • ISO 13485 surveillance audits
  • Corporate audits
  • Internal audits
  • Customer audits
  • Customer complaint investigation, reporting, closure and trending.
  • Support sites with any queries that may arise during their audits.
  • Review current technical product files for compliance to international requirements.
  • Answer all customer regulatory requests and complaints.
  • Design and implementing quality systems improvements.
  • Support plant validation documentation programs as required, ensuring records are maintained.

Qualifications and Experience

  • College graduate with Engineering or science degree or equivalent experience
  • Minimum 3-5 years' experience in a Medical device quality systems role in an FDA regulated environment
  • Previous supervisory experience essential
  • Qualified systems lead auditor for ISO 13485 and MDD compliance.
  • Competent in preparing written communication and correspondence.
  • Previous Regulatory experience an advantage

For more Information, please contact Kathryn on 016455250 or email

PLEASE NOTE: Candidates must have full working rights in Ireland i.e. (a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland) to be considered for this role.

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