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QA/RA Supervisor (Medical Device)

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Wexford
  • Sector: Science
  • Date posted: 12/01/2018
  • Job reference: J374057A

 

Our client, a global leader in the manufacturing of medical devices based in Wexford, has a requirement for a QA / RA Supervisor to join their team.

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 will be responsible for:

- Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System.

This will cover:

o Management of the PMR system.

o Change Control Process.

o 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.

Required 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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