Edwards Lifesciences Associate Analyst, Quality Systems (Contract) in Mississauga, Canada
Edwards Lifesciences (Canada) Inc. is the world leader in heart valve replacement and repair technology, and hemodynamic monitoring technology. Our leadership position comes from years of research and dedication in developing technologically advanced products that meet the demanding needs of clinicians and their patients.
This is an exciting opportunity to join our Quality team as the Associate Analyst, Quality Systems. The Associate Analyst will help maintain our quality systems by managing product dispositions, return inspections, and receiving damages, while ensuring compliance with corporate and international quality standards. This role will primarily support our quality operations team as the key contact for the warehouse. We are looking for a highly accountable self-starter who will provide exceptional operational support to help achieve key organizational objectives. *Please note, this role will be a 12 to 18-month contract opportunity.
Manage return inspection, product disposition, and receiving damages
Address any product quality concerns, including responding to warehouse questions and supporting any product recalls
Participate on cross-functional teams for quality systems projects
Recommend changes to documentation associated with quality systems
Generate quality system reports and review for accuracy
Participate in the implementation of business process improvement solutions for Quality systems
Participate on audit teams by responding and gathering data to address audit requests
Assess the impact of quality systems information (e.g. Enterprise Change Requests (ECRs) CAPA) and provide feedback to originators
Main point of contact for the warehouse
1 – 2 years previous related work experience
Experience with ERP systems (e.g. JDE)
Proficient computer skills in MS Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Good knowledge of medical or pharmaceutical regulations as relating to documentation, including basic understanding of medical device regulations (e.g. ISO 13485)
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment
Able to commute to offsite warehouse with own transportation, minimum twice per month
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.