Senior Manager, Quality Assurance Complaints

The Sr Manager, Quality Assurance Complaints will lead a team of QC (Quality Compliance) Specialists to assure complaint handling best practices, SOP's, and vigilance procedures are being effectively conducted and in compliance with applicable regulations. The role leads complaint handling with Edwards Lifesciences Critical Care QA organization.
Position is hybrid (onsite / remote blend), based out of the Edwards Lifesciences Corporate Campus in Irvine, CA.
Key Role Responsibilities
Manage and/or lead a small team within Quality Compliance. Develop team members to increase business acumen, functional skills and career development. Responsible for Complaint Handling and vigilance reporting for the assigned region(s)/BU(s)/plant. Stay up to date with international disciplines on related regulatory and compliance requirements related to the complaint system process.
Identify, and lead the implementation of business process improvement solutions for Quality Compliance processes and systems, including developing changes to procedures, to improve operation, efficiencies, and user experience, while supporting the integrity of the business process
Lead projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on teams with the support of the manager
Identify opportunities and lead the implementation of changes to drive improvements
Process owner for quality compliance processes and systems. Generate metrics, and draw inferences for improvement opportunities and needs.
Collaborate with team members to determine new training and training program improvement needs, and delivers training
Other incidental duties
Education and Experience
Bachelor's Degree in relative Business, Management or Quality / Regulatory Science field required. Master's Degree may offset some required experience.
People management experience required, including providing coaching and feedback responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
Progressive management experience in Complaints, Quality Compliance and / or Quality Assurance Management in a regulated industry required
Additional Skills and Expectations
Proven record of successful project management leadership
Advanced knowledge and utilization in Microsoft Office Suite (Outlook, Word, Excel, Power Point, Project)
Demonstrates high level problem-solving, analytical and critical thinking skills including high discretion/judgment in decision making
Exhibits professional communication (written / verbal) and relationship management skills
Extensive understanding of Quality Compliance procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline
Extensive understanding of related aspects of Quality Compliance processes and/or systems
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Builds relationships with peers, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Open to sharing information and develop solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
Thrives in a collaborative fast paced, dynamic, and constantly changing work environment
High accountability for the performance and results of a team within own discipline or function; advise to unit or sub-units and may become actively involved, as required, to meet schedules and resolve problems
Provide technical guidance to employees, colleagues and/or customers
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, the base pay range for this position is $123,000 to $174,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
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 18,500 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.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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