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


PLEASE APPLY DIRECTLY BY CLICKING HERE


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