Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
At Edwards Lifesciences, we’re committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards’ high ethical standards and continue to enable us to transform patient lives around the world.
The manager for Digital Quality and Compliance will be responsible for managing the sustainability aspects of the ePAC Program. This role will collaborate cross functionally with various areas of the organizations to develop a deep understanding of how Product Distribution Compliance is enabling Marketing, Regulatory, Labelling, Supply Chain and Quality Processes. The successful individual must have a combination of analytical skills, project management understanding, and business acumen with an ability to think enterprise-wide and support global operations. The manager would be comfortable with interacting with upper management and enforcing governance and providing expertise in development of technical solutions to optimize processes and systems.
How you will make an impact:
• Oversee the reengineering and optimization of business processes and systems. Act as a Subject Matter Expert (SME) in business processes in the area of responsibility.
• Configure and test systems to execute features, integration, and reporting
• Evaluate and validate functional business requirements against business needs.
• Translate the needs of business and articulate the functional design to meet requirements
• Manage and monitor global system enhancement requests for ePAC Program.
• Identify root causes and provide guidance for resolutions for testing and validation of processes and systems including perform complex root cause analysis and troubleshoot business processes including testing and researching data integrity/accuracy
• Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems.
• Provide design and architecture guidance to project teams to execute tactical projects / initiatives
• Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes
• Other incidental duties
What you'll need (Required):
• Bachelor's Degree or equivalent in related field, 8 years’ experience of previous related experience or equivalent work experience based on Edwards criteria
What else we look for (Preferred):
• Stay current with latest platform features
• Project management skills
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• Extensive knowledge in at least discipline (e.g. Analysis, Design, Development, QA/QC, etc.)
• Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Oracle, SQL Server.)
• Ability to learn and map platform ecosystem, business processes and integration points.
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to manage competing priorities in a fast paced environment
• Represents leadership on sections of projects within a specific area interfacing with project managers and team
• Consult in project setting within specific sections of area
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.