Description
I have an immediate opening for a Quality Systems Engineer with a leading medical device company based in South Dublin. This role will be an initial 12 month contract.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.
RESPONSIBILITIES:
- Be 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.
- Support production personnel in relevant continuous improvement activities (Six Sigma etc.)
- Be a primary contact for other departments providing quality advice / guidance to assure compliance.
- Coordinate QA systems and processes to ensure 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, Change Controls, GMP records and other Quality Management Systems Documentation as required.
- Responsible for 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.
EDUCATIONAL REQUIREMENTS:
A primary degree in a Science/Engineering discipline
RELEVANT EXPERIENCE:
A minimum of 5 years work experience in anISO orISO13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
- Proven working experience with FDA QSR and ISO 13485.
- Qualified 'lead auditor' experience desirable.
Six Sigma or similar statistical background would be advantageous
- Experienced in technical writing and review
- Experience in CAPA system management
- 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
If you feel you would be a good fit for this role please apply directly to this advert or contact Derek Sheridan on for further details. Sthree UK is acting as an Employment Business in relation to this vacancy.