Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Sr. Quality Systems Analyst position is a unique career opportunity that could be your next step towards an exciting future.
This role supports all Edwards business units, regions and site through the review, analysis, and evaluation of business needs to create solutions that support overall business strategies. The Senior Quality System Analyst is responsible for effectively partnering with subject matter experts, process owners and functional leaders across the organization in helping to document business requirements, defining scope and objectives that drive process development and implementation while promoting a collaborative atmosphere of quality awareness and continuous improvement. Interact and present to senior management through the escalation process to drive for simplification and standardization across the organization. Functions as an integrator between the business users, IT and corporate compliance with both business and technical expertise.
How You'll Make an Impact:
Support Corporate Quality strategic initiatives by working with business representatives to understand, and document the business requirements, processes and workflows developing both written and visual depictions of requirements and process flows. Partner effectively with all levels of the organization to drive results, proactively identify and resolve problems, manage conflicts and escalate as required. Work with IT to develop functional specifications and act as Subject Matter Expert for the proposed solutions. Work with the Corporate Quality PMO to ensure solutions are successfully developed, deployed and sustained in line with overall Corporate Quality objectives.
Lead medium to large scale projects where analysis of situations requires an in-depth evaluation of multiple factors and/or requires an in-depth knowledge of organizational objectives in conjunction with Quality / Regulatory compliance requirements. Drive to resolve these issues completely and with speed by leveraging your network of key contacts outside your own area of expertise. You will suggest and drive improvement of current practices and work with the appropriate functions to implement changes or participate in their implementation.
Other incidental duties assigned by Leadership
What You'll Need (Required):
Bachelor’s degree in a related field as defined by Edwards criteria
Minimum 5 years of experience in a quality and/or manufacturing environment within the medical device industry
What Else We Look For (Preferred):
Proven expertise in MS Office Suite
Good project management skills and related software tools preferred
Excellent written and verbal communication skills including negotiating and relationship management skills
Strong problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems
Full knowledge of medical or pharmaceutical regulations as relating to documentation
Full understanding of medical devices regulations (e.g., FDA (21 CFR Part 820) and ISO13485)
Strict attention to detail producing high quality work
Ability to interact professionally with all organizational levels. Strong ability to manage and work with different cultures and nationalities, experience working in complex global environment
Ability to manage competing priorities in a fast paced environment, show initiative and be flexible
Working experience influencing others to action who are not direct reports
Work is performed independently on complex projects and reviewed for accuracy and soundness
Applies sound judgment when making decisions and communicating with peers and management
Ability to adapt to new technologies and rapidly changing 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
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 $90,000 to $127,000 (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.