LivaNova is a world leader in Cardiac Surgery and a leading player in the treatment of Epilepsy. We are committed to applying our wealth of knowledge and technological expertise, acquired through decades of research and development to create therapies - products and services - that deliver the highest level of quality. Working at LivaNova isn't just a career; it's the chance to make a difference in the lives of more than one million patients every year, in over 80 countries. Our Burnaby BC Plant focuses on one main therapeutic area and that is the production of bioprosthetic heart valves for heart valve replacement surgery.
We seek a Senior Quality Engineer who will ensure compliance to all LivaNova Canada Corp. quality policies and procedures. Primary focus shall be on compliance to procedures, corrective and preventive actions, and process validations, with special emphasis on establishing validation requirements for software validation, support for current manufacturing processes, and product outcomes. For new product development assignments, the focus shall be on design assurance, conformance to external standards, and process (including software) validation.
Reporting directly to the Manager of Quality Operations, the successful candidate will ensure compliance to LivaNova’s corporate quality policies, as well as FDA (21 CFR Part 11) and ISO 9001/13485 regulations. The candidate will execute planned and systematic activities in a quality system so that quality requirements for a product or service are fulfilled:
- Review process validation planning, protocols and reports
- Investigate the cause of Verification &Validation failures
- Take disposition decision on nonconforming products identified in production
- Evaluate the risk posed on products already distributed; generate the QA report and identify quality process improvements based on trending data
- Conducting and overseeing investigations for in-process nonconformance’s, audit nonconformance’s and post market events to identify root cause and corrective actions in a timely and compliant manner
- Collaborate with operations to define and implement systems that enhance efficiency, productivity and quality.
- Own CAPA process and trend data to identify opportunities for CAPA and manufacturing process improvements
- Establish manufacturing product quality control plans
- Issue claim Card/SQN and collect evidence of effectiveness
- Manage the material disposition for change orders
- Identify opportunities of quality improvements in the production area and supervise implementation of the improvement plan
- B.Sc. in an Engineering or a Diploma in Engineering Technology (Mechanical, Biomedical)
- Knowledge of all relevant regulatory standards
- Proficient in problem solving using scientific method
- Excellent writing and communication skills.
To apply for this position please see the career section at: http://www.livanova.com/careers