LivaNova is a global medical device company and a leader in the treatment of cardiovascular and neurological diseases. The Company develops, manufactures and markets medical technologies for cardiac surgery, the treatment of cardiac rhythm disorders and epilepsy.
Our Burnaby Plant focuses on one main therapeutic area and that is the production of bioprosthetic heart valves for heart valve replacement surgery. We are currently seeking a newly created position for a Supplier Development and Process Leader.
The successful candidate will have the opportunity to:
Become the first Supplier Development & Process Leader on the site here in Vancouver, working collaboratively to collect root cause analysis, providing technical solutions as it relates to supplier quality with an innovative approach to quality cost and waste reduction, defect prevention while providing continuous improvement.
Build trust and credible relationships with our suppliers by offering technical support to them and ensure that their inhouse processes are compliant and inline with our procedures
Unlike the traditional approach of conducting only supplier process audit, you will have the opportunity to partner with suppliers to develop a new process design that is compliant with the end customer needs.
Here is what this opportunity will look like:
Qualification Supplier Process
Lead the supplier approval process by assessing manufacturing/technology capabilities and Health, Safety and Environmental Risks
Review supplier manufacturing processes, collaborate with suppliers on process improvement and value enhancement opportunities
Supplier Process Audit
Carry out supplier validation audits, with supplier support and supplier advanced product quality planning (APQP or PPAP, SPQR: Supplier Process Qualification Review)
Work with the supplier directly to create correction action plans to address process failures & improvement and value enhancement opportunities
Implement resolution for non-conformances in the supply to Livanova according to the company process requirement
Process Continuous Improvement
Conduct benchmarking studies to determine best practices/designs and future trends
Promote the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA)
Any change in the original product or process design must be review and approved by the successful incumbent prior to implementation
Quality System Management and Manufacturing system
Assures that the supplier or EM quality system audit function complies with QSR/GMP, ISO and other regulatory requirements
To be ready for this type of opportunity you will have earned your Engineering Degree or have at least five years of industry experience within the manufacturing process or in a quality SQE function. Experience in development will be a must. You will need to have experience with developing a culture of cost management and must have a very structured mindset for continued improvement. You will be traveling to suppliers and need to be autonomous in moving around the world, and able to integrate with the different cultures of our suppliers. Adaptability and understanding of different cultures will be critical in this role.
Demonstrate use of Quality tools/methodologies
Knowledge of Health Canada, FDA, GMP, ISO 13485, and ISO 14971
Advanced computer skills, including statistical/data analysis and report writing skills (Minitabexperience is a plus)
Experience implementing various product and process improvement methodologies,
Ability to work in a highly matrixed and geographically diverse business environment
Experience working with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria to ensure supplier process capability is sufficient to meet product and process requirements
LivaNova is a global medical device company and a leader in the treatment of cardiac surgery, neuromodulation and cardiac Rhythm Management. We are an organization of growth and change. As such, we seek exceptional talent to propel our company forward and continue our tradition of innovation and excellence in everything we do.