Senior QA Operations / Quality Systems Engineer (6 Month Contract)
To provide additional Quality Assurance support as required in the areas of Quality Management Systems and oversight of Subcontractors and Critical Suppliers to ensure that activities are performed in a manner that assures product quality and meets regulatory requirements
Take ownership for activities associated with Supplier Management. This includes supplier selection, approval, monitoring and reporting.
• Support the activities associated with preparing the QMS to achieve certification to FDA and PMDA regulations as well as the upcoming ISO13485:2016 and MDR requirements.
• Providing support to, and interacting with, the finished device Manufacturing Subcontractor & Suppliers to ensure that product quality requirements are achieved.
• Ensuring that Product manufacture and release activities are performed in a manner that is compatible with regulatory requirements & business needs.
• Reviewing and contributing to process validation activities of the Subcontractor & Suppliers.
• Driving SCAR, CAPA and NCR activities to closure, thoroughly and in a timely manner.
• Manage the field complaints handling system. Manage all complaints and drive complaint investigation so that complaints are closed out in a thorough and timely manner.
• Manage the Audit system. Manage the audit schedule and perform audits as required. Drive investigation into audit actions so that audit actions are closed out in a thorough and timely manner.
• Support Risk Management activities as required.
• Upwards of 7 years’ experience in a medical device manufacturing environment, with a number of years in an Operations QA role.
• Educated to a Minimum Diploma Level in an Engineering, Science or Quality Assurance discipline
• Experience in management of Complaints, CAPA, Audit Systems, Risk Management and Supplier Management is desirable.
• Ability to be the voice of Quality when dealing cross functionally, and will take the lead on discussions / meetings to ensure an appropriate outcome.
• Excellent attention to detail, communication skills, people and team working skills.
• Excellent problem solving skills.
Contact Brian Christensen on 01 6854747 or submit your CV to firstname.lastname@example.org for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747