Manager, Clinical Product Quality

The Manager, Clinical Product Quality provides medical/clinical guidance to Critical Care stake holders regarding complaints, product development, risk management and product education. This role is a hybrid (office remote mix). Selected candidate must reside (or be willing to relocate) within a reasonable commuting distance to Irvine Corporate office and able to commute to office as needed. Key Responsibilities: • Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, required regulatory reporting (MDR, MDV, etc.), and complaint closure. Author and/or review complaint conclusions/closure statements and customer letters. May assist with and help manage Imaging Reviews. • Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution. • May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures. • Perform complaint trending analyses, participate in quality metrics review meetings. • May analyze and interpret aggregate complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report including ad hoc report summaries. • Communicate complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations • Support process improvement projects as needed. Required Education and Experience: Bachelor's Degree in related field , plus a minimum of eight (8) years relative experience in Medical Device Industry, Quality Systems, hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) required Masters Degree will offset two (2) years of required experience Professional experience in a large manufacturing company preferred Additional Skills & Expectations: • Extensive understanding of FDA’s Quality System Regulation • Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements. • Proven record of project management – acting as consultative subject matter expert within specific sections of quality compliance area • Strong presentation and public speaking skills • Advanced expertise in Microsoft Office Suite (including advanced Excel) and QMS (Quality Management System) • Demonstrates excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives • Ability to manage competing priorities in a fast paced environment • Represents leadership on sections of projects within a specific area interfacing with project managers and quality compliance team • 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 $111,000 to $158,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. 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. 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.

Salary : $111,000 - $158,000