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.How you will make an impact:
Coordinate and assure a high level of customer service for all microbiology based testing and sterility assurance strategies for Edwards’ manufacturing.
Develop and execute robust talent development plan in alignment with functional growth strategies of the department.
Oversee/direct the development, implementation, and maintenance of training programs to ensure adequate training of personnel on Quality processes and documentation.
Plan and direct strategic quality management activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, defining alternative solutions and resolving issues in collaboration with cross functional groups.
Anticipate/eliminate complex quality issues and support timely resolution in collaboration with R&D, Manufacturing Engineering, Operations, Quality and other departments.
Oversee the audit management process of external inspections (e.g. FDA, Notified Bodies, and other regulatory authorities) including timely closure of post approval commitments, responding to inspections/audit, and resolving open issues with regulatory agencies.
What you'll need (Required):
Bachelor's Degree in in related field, 14 years related experience in a laboratory and skill levels exceeding the requirements of the previous level
OR Master's Degree and 12 years previous related experience.
Demonstrated track record in management of technical and/or regulated disciplines
What else we look for (Preferred):
Proven successful project management leadership skills
Experience working in a regulated industry
Proven expertise in both Microsoft Office Suite and related systems
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to lead a team of highly skilled scientists
Knowledge of financial acumen as it relates to the business as well as laboratory operations
Demonstrated ability to direct teams 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 engineering to the business
Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
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
Interacts with senior management, and others concerning matters of significance to the company
Conduct business and technical briefings for senior and top management and for external representatives
Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
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 $187,000 to $265,000 (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 RequirementEdwards 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.