Quality Assurance Engineer – Burnaby BC
LivaNova is a world leader in Cardiac Surgery and a leading player in Cardiac Rhythm Management. 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
We seek a Quality Assurance Engineer who will ensure compliance to all LivaNova Canada Corp. quality policies and procedures. For new product development assignments, the primary focus shall be on design assurance, conformance to external standards, and process (including software) validation. For sustaining product assignments, the primary focus shall be on compliance to procedures, corrective and preventive actions, and process (including software) re-validations
Reporting directly to the Manager of Quality Operations, the successful candidate will ensure compliance to LivaNova’s corporate quality policies, as well as FDA 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 will be fulfilled:
- Develop all the planning processes and procedures in order to try to make sure that the products manufactured or the service delivered by the organization will be of good quality.
- Ensure compliance Monitor the development process throughout its entire cycle (e.g., performing audits and reviews) comparing the results with the processes and standards defined in the organization, making sure you are doing the right things, the right way, the first time
- Develop thorough and practical engineering solutions to quality assurance or quality control problems.
- Performs process and equipment validation and related activities.
- Lead the development of quality systems for new products. Develop improved inspection/test methods and procedures as part of any product quality system.
- Assure capability to produce product with respect to: availability of materials, released equipment and processes, environment monitoring, and training.
- Write, execute and report test plans based upon the scientific method. These test plans shall address hypothesis of problems identified during product development or monitoring of ongoing production
- Provide expertise in quality engineering to areas supported. (e.g. statistical tools, interpretation of US FDA and international quality systems regulations, packaging testing, QA policy requirements)
- Represent the organization in providing solutions to difficult technical problems associated with specific projects/processes.
- Prepare training materials and coach trainers in relevant areas of support
- Develop creative technical solutions to complex quality problems where analyses of situations or data require an in-depth evaluation of intangible variables. (i.e. develops efficient solution preparation and testing).
- Perform gap analysis when standards change to demonstrate product safety and efficacy.
- Perform product and process risk assessments.
- B.Sc. in an Engineering or a Diploma in Engineering Technology (Mechanical, electrical, etc..)
- Knowledge of all relevant regulatory standards
- Proficient in problem solving using scientific method
- Excellent writing and communication skills
- Five years of engineering or quality experience in a regulated industry
- Knowledge of related LivaNova processes and products
To apply for this position please see the career section at www.sorin.com.
Posted: February 23, 2017
Closes:April 24, 2017