Quality Assurance Engineer Medical Devices
|Contact Name:||Laurentina Kennedy|
QA Engineer Device Development will join the Global Device Development team as a Device Development Assurance Engineer working in collaboration with QA function. Global Device Development support at site levels a large portfolio of medical devices/combination drug delivery systems with emphasis on driving best practices & compliance initiatives.
Provide technical support in documenting & maintaining the GDD Quality Management System through knowledge & understanding of ISO13485, 21 CFR 820, 21 CFR Part 4 Compliance, & MDD 93/42/EEC, Annex 1 "Essential Requirements" with linkage to Directive 2001/83/EC Medicinal Products for human use, and the recently released Medical Device Directive.
Proven track record in the application of risk management ISO14971 and associated tools.
Responsibility for generation and review of Core SOP's to support development and maintenance of the Quality Management System.
Represent the Device Development Assurance group at a project level providing support and guidance to ensure programs adhere to the GDD QMS.
Support the internal audit program with support throughout the team.
Support the reporting, investigating and trending of device related, complaints, technical investigations, CAPA's, internal audits, & Change control, with linkage to Management Reviews.
Degree in /Chemistry/Biomedical Science, Engineering or equivalent, with demonstrable experience within a compliance/ quality role.
Experience within a medical device and container closure systems environment with emphasis on drug delivery technologies would be a distinct advantage.
Experiences of compliance within Quality Management systems and regulatory requirements essential.
Excellent technical report writing skills.
Sound problem-solving abilities.
Experiences of conducting internal audits and hosting/preparation for external audits.
Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines.
Willingness to travel as necessary between the Global Device Development Teams.
A team player willing to support any other organisational needs/activities outside primary expertise to continuously enhance the Global Device Development group.
For further information on this QA Engineer Medical Devices position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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