The primary purpose of this job is to act as the communication cord between the leadership and the employees. Oversees quality system metrics and data providing work direction for Quality Engineers and Quality Technicians to support and maintain quality management system, risk management and quality control plans. Responsible and directs activities for one or various functions within the quality department. Areas of responsibility may include but not limited to the following areas: Quality Engineering, Quality Operations, Quality Projects. Also collaborates in the process design and design transfer activities ensuring that adequate systems are properly validated and qualified to ensure to meet product requirements.

Key Responsibilities:

• Supervise and mentor quality operations engineers and technicians.

• Collaborate with multidisciplinary teams to conduct investigations of non-conformances and recommend corrective and preventive actions, audits, validations and in process changes.

• Promote multifunctional team approach and Edwards cultural beliefs while ensure that expected project output meet the Quality System requirements.

• Responsible for leading multifunctional teams to develop the quality planning through risk assessment activities, creating and maintaining files including Process Map, FMEA and others applicable documents.

• Ensures that direct reports are appropriately trained for their respective job functions

• Review the adequacy and correctness of PMAPs, FMEAs, Control Plans, AQP, validations (protocols and reports), documentation changes and non-conformance investigations.

• Lead and support in continuous improvement projects.

• Organizes QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.

• Other incidental duties

Education and Experience:

Bachelor's Degree in in Science or Engineering field previous related experience, required

Master's Degree or equivalent in related field, preferred

Experience working in a regulated industry, preferred

Additional Skills:

• Proven successful project management leadership skills

• Proven expertise in Microsoft Office Suite and related tools and systems

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Extensive understanding of Quality Engineering procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own discipline

• Proven skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of Quality Engineering to the business

• 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 work and excel within a fast paced, dynamic, and constantly changing work environment

• 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

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.