- Provide guidance to stakeholders on the evaluation and analysis of complex technical information and data related to Training program quality indicators, identifying trends and driving factors, and recommending course corrections. Develop presentations and procedures and present summaries of trends, potential root causes, and recommended course corrections. Develop and lead the evaluation of impact assessments related to Engineering Change Requests (ECRs) submissions. Assess global requirements in the development of training course and/or exam/certification training materials. Evaluate training materials and ensure local/global sustainability (e.g., revision control, accuracy)
- Interpret internal requirements and external regulations and standards as they relate to training and implementing measures to meet those requirements.
- Identify and assess training related root cause and lead the implementation of corrective actions in initial non-conformance investigations
- Provide complex analysis on training course materials to evaluate, provide recommendations and lead the implementation on appropriate training effectiveness measures
- Develop and present training materials for quality system related processes
- Lead the design and development of complex technical and non-technical instructional activities using various media and related training materials and tools to achieve learning objectives while provide guidance and proactively engaging stakeholders
- Contribute process knowledge to, and develop proposed modifications while identifying new alternatives to resolve complex issues on Quality, Engineering, and Manufacturing projects, as part of cross-functional technical groups.
- Summarize data to develop routine criteria for evaluating effectiveness of training activities
- Provide coaching and knowledge transfer to other team members
- Perform adhoc LMS functions to address the business needs
- Bachelor's Degree in in related field
- 5 years' experience of previous related experience
- Experience working in a medical device, healthcare, or a similarly regulated environment
- Experience with 'Learning Path' Learning Management Systems (LMS)
- Excellent computer skills in MS Office Suite
- Good written and verbal communication skills including negotiating and relationship management skills
- Excellent problem-solving and critical thinking skills
- Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality compliance
- Full knowledge of Good Documentation Practices (GDP)
- Full knowledge of the capabilities within Learning Management System (LMS)
- Full understanding of quality system regulations
- Good leadership skills and ability to influence change
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
- 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
-
Manager, Quality Training
1 day ago
Edwards Lifesciences Irvine, United StatesImagine 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 pro ...
-
Senior Specialist, Quality Training
6 days ago
Edwards Lifesciences Corporation Irvine, United StatesImagine how your ideas and expertise can change a patients 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 Training, Quality, Specialist, ...
-
Quality System Specialist
6 days ago
Planet Innovation Irvine, United StatesPlanet Innovation (PI) is a globally recognised Healthtech Innovation and Manufacturing company. PI offers the full spectrum of product design, engineering and manufacturing services for its customers in the diagnostics, life sciences and healthcare industries. Our clients includ ...
-
Document Control Associate
3 days ago
Biomerica, Inc. Irvine, United States**Document Control Associate (IVD Medical Device, Immunoassay)** · **Biomerica Irvine, CA USA** · At Biomerica, we improve lives by developing, manufacturing and marketing products designed to enhance the health and well-being of people, while reducing healthcare costs. We are a ...
-
Ems Nurse Supervisor
1 day ago
Orange County Fire Authority Irvine, United States**DESCRIPTION**: · The Orange County Fire Authority (OCFA) is currently recruiting to fill one (1) vacancy in the Emergency Medical Services (EMS) Division of the EMS & Training Department, for the position of EMS Nurse Supervisor. This recruitment will be used to fill the curren ...
-
Manager
3 days ago
RollEmUp Irvine Spectrum Irvine, United States**Benefits** · - We offer many great benefits: · **Responsibilities**: · *Train employees and monitor operations to ensure customers expectations are exceeded *Manage back of the house employees to provide exceptional food quality in a timely and cost effective method *Schedule, ...
-
Document Services Associate
6 days ago
Pacific Premier Bank Irvine, United StatesThe Document Services Associate performs document Quality Control review, utilizing the banks taxonomy as a guide. Verifies that documents in PPBI's system of record are in the proper placeholder; on the correct loan; dated correctly; pages rotated correctly; separate documents a ...
-
Dry Cleaner Spotter
5 days ago
View Cleaners Irvine, United StatesView Cleaners is a quality cleaner, utilizing modern equipment to produce high-quality cleaning while achieving high production standards. Production is fast-paced with a workload that changes daily and seasonally. · Job Duties: · - Stain removal for dry-cleaned and laundered ite ...
-
Quality Regional/quality Document Control
5 days ago
ABO Plasma Irvine, United States**Classification: Salaried/Exempt** · **Reports to: Director of Quality Assurance & Regulatory Affairs** · **PURPOSE** · Assist the Director of QA/RA in achieving center quality goals while ensuring centers adhere to Standard Operating Procedures, Current Good Manufacturing Princ ...
-
Supervisor I, Manufacturing
6 days ago
B. Braun Medical Inc. Irvine, United StatesOverview: · **About B. Braun** · B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and com ...
-
Lead Manufacturing Operator
1 week ago
Axonics Modulation Technologies Irvine, United States**FLSA** · - Hourly, Non-Exempt**Department** · - Operations**Reports To** · - Production SupervisorGeneral Description: · The Lead Manufacturing Operator will focus on instructing and monitoring production operators in the building of Axonics products. This involves working in a ...
-
Associate Director, Marketing Compliance
6 days ago
AbbVie Irvine, United States**Company Description** · Purpose · Describe the primary goals, objectives or functions or outputs of this position. · Responsible for leading the Compliance Training team in the US Therapeutics Compliance Operations within TA&O. This team will prioritize, design and deliver digi ...
-
Vice President of Operations
1 day ago
Discovery Behavioral Health DBH Irvine, United States**Company Description** · At Discovery Behavioral Health, we know the best way to predict the future of healthcare is to create it. As a member of our growing team, you will have a voice in the creation of life-changing programs and treatment centers nationwide. Working collabora ...
-
Ct Tech Ii
3 days ago
Hoag Memorial Hospital Presbyterian Irvine, United States**Salary Range**: $ $ /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education. · The CT Technologist II is a state and nationally registered professional, who under the direction of the technical supervisor and medical directo ...
-
Detailer
5 days ago
Tuttle Click Ford Lincoln Irvine, United StatesTuttle Click Ford Lincoln is looking for a full-time auto detailer, they will be responsible for cleaning and refurbishing new and used automobiles. · **Schedule Hours**: · Weekdays 11:00 a.m. -8:00 p.m. · Saturdays 10:00 a.m. - 7:00 p.m. · Sundays 10:00 a.m. - 6:00 p.m. · **Comp ...
-
Regional Director of Operations
1 day ago
Discovery Behavioral Health DBH Irvine, United States**Company Description** · At Discovery Behavioral Health, we know the best way to predict the future of healthcare is to create it. As a member of our growing team, you will have a voice in the creation of life-changing programs and treatment centers nationwide. Working collabora ...
-
Duplex Finishing Line Operator
6 days ago
B. Braun Medical Inc. Irvine, United StatesOverview: · With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, s ...
-
Medical Receptionist
1 day ago
Radnet Management, Inc. Irvine, United StatesOverview: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of our success is its people w ...
-
Technical Writer
6 days ago
Prismatik Irvine, United States**Essential Functions**: · - Creates Standard Operating Procedures (SOPs) for new procedures for Quality Management System incorporating requirements to meet 21CFR 820; maintains and updates current SOPs. · - Generates, updates, and maintains documents in response to regulatory f ...
-
CTC Global Corporation Irvine, United StatesSets up**Job Details**:Bend Test Operator 1st Shift, Tuesday to Saturday (5:30 AM to 2:30 PM) · **Salary**:$20.25 Hr. · (eligible for a Quarterly Bonus) · **JOB SUMMARY**: · Sets-up and operates a machine to that tests the composite core in a prescribed quality control process in ...
Senior Specialist, Quality Training - Irvine, United States - Edwards Lifesciences
Description
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 ensure that Edwards has the key quality information necessary for regulatory complianceHow you will make an impact:
Incidental:
Other duties as assigned by management
What you'll need (Required):
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 $78,000 to $110,000 (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 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.