Product Quality Clinician Manager

Edwards Lifesciences • Irvine, CA

10d • $126,000 - $178,000

About The Position

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. You will also collaborate across teams to uphold safety and integrity throughout the entire product lifecycle. By contributing clinical expertise and optimizing development processes, you'll help drive innovative technologies that improve patient outcomes globally. In this role, you will provide clinical expert knowledge and clinical guidance to Quality Engineering and other cross functional teams to understand the nature of complaints and possible health risks.

Requirements

• Bachelor's Degree or equivalent in a related field or equivalent work experience based on Edwards criteria
• Eight years of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care RN, Practitioner, Physician, ICU, OR, or cardiovascular/endovascular interventions)

Nice To Haves

• Experience working in a large manufacturing company
• Recent direct patient care in cardiac critical care or a cath lab, e.g., Registered Nurse, CST, PA, MD or Practitioner.
• Proven successful project management skills
• Strong presentation and public speaking skills
• Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
• 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.
• 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 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
• Consult in project setting within specific sections of quality compliance area
• Provides quality compliance leadership to outsourcing partners on a task level
• 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

Responsibilities

• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.).
• 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.
• Other incidental duties

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees