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.Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.How you'll make an impact: Assigning work to lower level employees ensuring balanced work along lines and across shifts, which may include establishing work schedules Performing visual, dimensional, and functional inspection across all components and/or finished medical device products using all applicable tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications - working independently at the highest levels of productivity Performing functional testing of finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications Reviewing, following and performing job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and may enter information into JDE. Performing verification of manufacturing documents with component and device drawings, which may include Geometric Dimensioning and Tolerancing methodologies May control inventory to ensure appropriate storage conditions and movement Training colleagues from other sites, including inspection of their work output Providing coaching and training to lower level employees and colleagues; Identify and escalate work issues and able to fill-in for Supervisor as needed Other incidental duties: General work area housekeepingWhat you'll need (Required):H.S. Diploma or equivalent Preferred2 years experience Specifically in sewing, GMP, clean room, medical device environment RequiredWhat else we look for (Preferred): Demonstrated ability to lead teams, coach others, and transfer knowledge Ability to use all applicable tools and equipment, hand eye coordination, and high manual dexterity Full understanding of applicable inspection procedures, including the ability to contribute to and support the development of procedures Proficient in all inspection techniques for production inspection Ability to provide performance feedback, confirm understanding, and have a positive impact on competency and output of other inspectors Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System) Ability to program and contribute to the validation of automated test equipment Strong communication skills and interpersonal relationship skills, including ability to convey training in methodology and procedures Ability to serve as a role model to lower level inspectors in proper execution of day-to-day inspection duties as well as guide other workers/colleagues in understanding operations and quality standards Strong English language skills, including reading, comprehending, speaking and writing, and strong communication skills Proficient computer skills, including strong working knowledge of manufacturing software Strict attention to detail Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Must be able to work with minimum supervision Work in a Team 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/control Candidate will be required to pass basic English skills assessmentAligning 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 (CA), the base pay range for this position is $56,000 to $76,000 (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.
Job Details
ID | #53707148 |
Estado | California |
Ciudad | Irvine |
Full-time | |
Salario | USD TBD TBD |
Fuente | Edwards Lifesciences |
Showed | 2025-03-24 |
Fecha | 2025-03-25 |
Fecha tope | 2025-05-24 |
Categoría | Etcétera |
Crear un currículum vítae | |
Aplica ya |
2nd Shift Lead Inspector
California, Irvine, 92602 Irvine USA