Quality Director

Description:

As Director of Quality, you will act as the key person for QA/DA and RA, promoting a commitment to patient safety, customer satisfaction and product quality. This is an excellent opportunity for a highly technical senior Quality Management professional to join an experienced, innovative team of SMEs who are working to disrupt the market in the structural heart space.

Responsibilities

• 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.

• Co-ordination of technical documentation including design history files, design verification and validation plans, protocols, risk assessments and reports for designated projects.

• Manages and executes key elements of DHF, Sterlisation, Biocompatibility etc.

• Set up Quality System appropriate to requirements and ensure the administration maintenance, management of the System, including leading on Continuous Improvements to meet evolving expectations of partners and to assure compliance with current international regulations and ISO standards.

• Prepare for and complete submissions to regulatory bodies, and manage follow up communications.

• Act as Management Representative for the Quality System.

• 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