Description
My Client a fast paced an innovative start up medical device company is seeking a QA/RA Specialist to Join there team.Job Purpose-Assuming responsibility as the key person for DA , QA and RA on what is a very new repair technology for heart valves.
-Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality in the company
-Understanding and complying with the company's quality, business, health & safety systems and market/legal regulations.
-Removing or mitigating against risks associated with the design, use and manufacture of the company's devices.
-Ensuring their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work
Key Responsibilities
-Interfaces with other functions in a team environment providing Design Assurance and Quality systems input.
-Performs Project Management as needed
-Actively participates in specification development in relation to design input development
-Provide direction to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects
-Develops design verification and validation plans, protocols, risk assessments and reports
-Co-ordinates the design history files for designated projects
-Identifies & interprets changes in systems or procedures, which could potentially affect compliance as they relate to assigned projects.
-Works within the quality system and ensures that the quality policy and company systems and procedures are complied with, in line with the Medical Device Directive and FDA Quality System Regulations
-Direct support for ISO inspections and registrations
-Review change control for designated projects for quality assurance implications
-Manage supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier's methods, supplier audits, management of supplier corrective and preventative actions
Skills, Qualifications & Experience
-A graduate of Engineering/Sciences with Minimum 5 years experience in a pharmaceutical/Medical Device environment
-Design for Manufacturing and Six Sigma experience is a plus.
-Demonstrable ability to work in a multi-disciplinary, regulated environment
If you are interested in this great oppottunity please contact me Anna Mooney . Or apply below with an up to date CV.
To find out more about Real please visit www.realstaffing.com