Quality Systems Engineer

Dublin South  ‐ Onsite
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Keywords

Description

I have an excellent opening for a Quality System Engineer with a leading medical device company based in Dublin.

Reporting to the Quality Systems Manager, duties will include implementing & maintaining the Company's Quality Management System in accordance with ISO 13485 and FDA CFR 21 Part 820. This role will have primary responsibility for managing the customer complaints process.

RESPONSIBILITIES:
* Be a key driver of cGMP practices within Operations and Quality divisions
* Provide support for the ISO13485 and 21CFR Part 820 Quality Systems
* Act as customer liaison contact for given key customers as appropriate.
* Review, analyse and report on relevant customer complaints
* Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues
* Be a primary contact for other departments providing quality advice / guidance to assure compliance.
* Manage compliance with relevant GMPs and promote quality improvements
* Provide a quality review on a range of quality documentation including, SOPs, Policies, Guidelines, Specifications, Investigations, Complaints, GMP records and other Quality Management System Documentation as required.
* Ensuring adherence to internal and external regulatory requirements
* Become an active member of the site internal audit team, liaising with Regulatory auditors
* Review, analyse and report on relevant customer complaints
* Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues
* Periodically review quality systems and practices for improved efficiencies and to assure greater compliance.

RELEVANT EXPERIENCE:
* A minimum of 5 years work experience in an ISO or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
* Proven working experience with FDA QSR and ISO 13485.
* Experience in managing customers and the complaints process is essential
* Qualified 'lead auditor' experience desirable.
* Six Sigma or similar statistical background would be advantageous
* Experienced in technical writing and review
* Proven ability of working in a cross-functional team environment.
* Excellent interpersonal and communication skills and high level of computer literacy.
* Good understanding of cGxPs
* Significant experience working within an established Quality System
* Primary degree in a Science/Engineering discipline

This is an excellent opportunity to join a fantastic company on a permanent basis, if you are interested in this role and feel you'd be a good fit please apply directly to this advert or contact Derek Sheridan on for further information.
Start date
03/2015
From
Real Staffing
Published at
09.02.2015
Project ID:
847864
Contract type
Permanent
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