Product Quality Clinician Manager - Edwards Lifesciences
Irvine, CA
About the Job
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 provide clinical expert knowledge and clinical guidance to Quality Engineering and other cross functional teams.
How you will make an impact:
• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.).
• Review and approve as a licensed or certified clinician.
• 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
What you'll need (Required):
• Bachelor's Degree or Equivalent in related field
• 8 years’ experience of experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions)
What else we look for (Preferred):
• Recent direct patient care in cardiac critical care or a cath lab, e.g., Registered Nurse, CST, PA, MD or Practitioner.
• Direct Quality Complaints experience in FDA MDR
• Experience working in a large manufacturing company
• 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
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 $120,000 to $170,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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.
How you will make an impact:
• Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.).
• Review and approve as a licensed or certified clinician.
• 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
What you'll need (Required):
• Bachelor's Degree or Equivalent in related field
• 8 years’ experience of experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions)
What else we look for (Preferred):
• Recent direct patient care in cardiac critical care or a cath lab, e.g., Registered Nurse, CST, PA, MD or Practitioner.
• Direct Quality Complaints experience in FDA MDR
• Experience working in a large manufacturing company
• 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
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 $120,000 to $170,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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.
Source : Edwards Lifesciences
