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Job Details

Lead Quality Systems Engineer

Company: Thornshaw Recruitment
Reference: TD9886
Closing Date: 12 Jan 19
Type: Permanent
Salary (£): Negotiable

Job Summary:

On behalf of my client, a global medical device company we are recrutiing for a Lead Quality Systems Engineer. Full time permanent position.


On behalf of my client, a global medical device company we are recrutiing for a Lead Quality Systems Engineer. Full time permanent position.

The Role:

You will be responsible for ensuring the effective and efficient deployment of the Quality System within the EMEA.

We are looking for candidates seeking a new challenge and that meet the following criteria:

3rd level qualification, a minimum of 4 years. 

Minimum 5 years experience in a Medical device industry or a similar environment.

Experience with CAPA, Change Management, Supplier Quality Assurance and Risk Management is required.

Knowledgeable in Quality Systems and Medical Device Regulations

Ability to work on own initiate, be proactive and propose viable solutions to meet the business and customers needs.

Good communication skills, both oral and written.

Desire to lead change whilst meeting both the Business and Regulatory requirements. 

Key Responsibilities: 

Your role will be to manage and maintain the EMEA Quality Management System in compliance with the Products Business Unit Quality System and the relevant applicable standards and regulations, i.e. ISO, GMP, FDA including but not limited to the following processes:

Quality System Management: Management Review, Internal Audits, Document Control and Quality System Planning.

Training: Co-ordinate / lead quality system related training sessions for cross functional team attendance.

Supplier Management: Assure appropriate levels of controls and management of suppliers that have an impact on product quality and the Quality System.

Distribution: Assure support and control to the EMES distribution center.

Vigilance Reporting: Ensure on time reporting of vigilance reports and follow up relevant EMEA Competent Authorities and Notified Bodies.

CAPA/ NC: Maintain compliance with requirements as well as escalating to upper management any major or critical nonconformance that may result from audits and/or any element of the Quality system.

Field actions: Assure timely and efficient execution of field actions in the EMEA.

For full details and job spec call Tina +353 1 2784671 or email your CV to

Apply for this job: Lead Quality Systems Engineer

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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