QA Documentation Specialist
Company: Thornshaw Recruitment
Closing Date: 24 Nov 16
Salary (£): Negotiable
Our client, a leading medical device company, is currently searching for an experienced QA Documentation Specialist. Candidates must have experience with the HPRA.
In this role, you will have responsibility for the following;
- Key member of the Operations Management Team and Corporate Quality Team.
- ISO9001 Management representative (ISO9000, 220.127.116.11, ISO 9001, 5.5.2), ISO 13485.
- Control of the Quality Manual including preparation, revision and execution.
- Responsible for organising Management Review and compiling and reporting on the performance of the quality system.
- Management of the product review and release system and signature on Certificates of Conformity.
- Management of Change Control and Document Control Systems.
- Issuing, control and filing of all batch related documentation.
- Responsible for final sign-off on all product labels, package inserts and Marketing Material.
- The organisation of product and facility inspection, preparation of procedures and instructions including certification assessment and surveillance audits, FDA inspections, other regulatory inspections and supplier audits.
- Ensuring that validations are performed on equipment, processes and software used in manufacturing and testing of product.
- The Management of non-conformance and corrective and preventative action systems including the control of further processing and delivery of non-conforming product until any deficiencies or unsatisfactory conditions have been corrected.
- Responsible for coordination of issuing Product Safety Notifications or Product Recalls as well as Medical Device Reporting (MDR) with the Vice President of Regulatory Affairs.
- Key participant in design control.
- Assist with FDA regulatory submissions with the Vice President of Regulatory Affairs.
This is a senior role with responsibility for all aspects of quality. We are searching for a high calibre candidate with the following background and experience:
- Primary degree qualification in a science, engineering or business discipline or equivalent in terms of relevant operational experience
- 5-7 years + industrial experience with preferably three years or more in the IVD industry.
- Must have experience in project management of change programs
- Firsthand experience of audits by regulatory authorities. Ideally will have hosted and lead FDA and other regulatory authority audits.
- Extensive experience of developing and delivering effective training on Quality Systems and Processes
- Demonstrated track record and success in team building skills
- Demonstrated experience of people management
For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671