QA RA Engineer

Quality Engineer (Design Assurance & Quality Assurance)
Our client a start up medical device company currently seeks a QA/RA Engineer to join their team. Successful candidate shall report to the Quality Manager or designee and must have a have experience in area of design control. The role will provide a Quality Engineering resource to support the product realisation process ensuring compliance with the requirements of ISO 13485:2003, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and the Quality Management System.

Role/Responsibilities:
Support design teams to ensure design documentation meets the company and regulatory

Requirements

• Generate quality and technical documentation to support design activities and quality system requirements including maintenance of Design History Files


• Support design teams on the preparation of risk analysis and essential requirements assessment


• Summarize, analyse, and make appropriate recommendations from test results or other process related findings including analysis of test data to establish performance standards for newly implemented or modified products/processes


• Write (in conjunction with the design teams) design verification and validation plans, protocols and reports


• Assist teams with the writing of process validation and software validation protocols and reports


• Compile technical files and design dossiers.


• Support the planning, and execution of regular design reviews


• Support the implementation of testing in compliance with ISO/MDD standards.


• Work with quality manager to maintain and develop the existing Quality Management System


• Support compliance to product quality standards and specifications.


• Support the preparation of regulatory submissions as directed by Management.


• Support the Product Realisation Teams as new products are developed and launched to market.


• Support the quality department in relation to documentation control, calibration, systems management and administration.


• Assist with validation techniques and associated regulatory requirements including design verification, design validation, process validation.


• Demonstrate best QA practices in line with the company objectives.


• Support project teams in the development of risk analysis documentation


• Implement effective controls on manufactured and purchased components, to include Vendor approval activities


• Support Quality training activities


• Support the customer complaints/vigilance process


• Support the internal and external (supplier) audit programmes


• The ability to implement quality improvement programmes


• Provide audit support for Notified Body, FDA and other regulatory agencies

Skills/Experience:

• Degree qualified in QA, Science or Engineering


• Minimum 5 years experience in a Quality Role in a Medical Device Environment, with Design Control experience a significant advantage


• Knowledge of risk management activities - ISO14971


• Validation experience


• Working knowledge of FDA QSR and ISO13485


• Experience in use of statistical techniques


• Desirable to have knowledge of sterilisation techniques


• Strong proven problem solving skills


• Excellent planning and coordination skills


• Excellent verbal and written communication skills


• Ability to work within a team environment to achieve agreed project milestones


• Ability to communicate quality/regulatory concepts effectively


• Proficiency in use of desktop software applications (e.g. MS office)

If you would like further Information you can contact the recruiter directly:

James Cassidy | Tel: +353 (0) 1 5079250