Sr. Principal Quality Engineer - Clinical & Regulatory Systems

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. As the Sr. Principal Quality Engineer, you will be responsible supporting the health of multiple Quality Sub Systems (e.g. Clinical Compliance, Regulatory Intelligence, Quality System Management Planning) and interacting with various internal and external groups, regulatory bodies and driving towards clear actionable insights, informed decision making and implementing necessary changes to ensure seamless compliance and the highest standards of quality.How you will make an impact: Identify, lead and provide business process improvement solutions for Clinical Compliance systems, including creating reviewing and approving changes to procedures and processes, to improve operation, efficiencies, and user experience. Lead complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams Drive investigations of moderate problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs Manage Edwards Quality System Planning and develop, review and approve changes to associated documentation to ensure clarity and effectiveness of program Facilitate the interpretation of external regulatory changes and coordinate impact assessment reviews in relation to existing internal requirements, ultimately leading to cross functional awareness, approval and as needed Quality System action planning. Lead the continuous utilization and improvement of the Edwards Regulatory Applicability matrix and its associated declaration forms & to ensure completeness of content, clarity and efficiency in usage throughout the global region. Develop and manage comprehensive processes and workflows to ensure investigational device accountability, clinical compliance and Clinical Affairs training plans are in accordance with regulatory and company requirements. Develop and deliver training programs for Clinical Affairs teams on best practices, trends, regulatory requirements and updates and published guidance, policy and procedure updates, etc. Responsible for Quality System planning responsibilities for significant initiatives and efforts aimed at Quality system compliance and effectiveness improvements. Ensure timely and accurate investigational device inventory to include management of forecasting, par levels, expiration dates, shipment initiation and returns according to regulatory and company guidelines Interprets internal or external business issues and recommends solutions/best practices Other incidental dutiesWhat you'll need (Required): Bachelor's Degree 10 years’ experience Or Master’s Degree or equivalent 8 years’ experience of previous related experience in quality systems, clinical and regulatory aspects of medical device technology and skill levels exceeding the requirements of the Manager required experience.What else we look for (Preferred): Experience working in a regulated industry preferred Able to represent leadership and consults in a project collaborative setting Excellent facilitation and presentation skills Excellent problem-solving, organizational, analytical and critical thinking skills Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas preferred Other: Certification in related discipline (e.g., Six-Sigma Black Belt, ASQ Certified Quality Engineer (CQE) or ASQ Certified Biomedical Auditor (CBA)) Preferred Experience with Class II & III medical devices preferred Proven successful project management leadership skills Proficient 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 Expert knowledge of international regulations of Good Clinical Practice (GCP) Expert understanding of clinical compliance procedures while identifying applications of functional knowledge and existing methodologies to complex problems Expert understanding of broad cross-disciplinary and in-depth knowledge of the clinical profession Expert knowledge of financial mechanism that relates to clinical compliance Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical compliance 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/controlAligning 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 $136,000 to $192,000 (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.