Assesses devices in-process and upon completion to ensure regulatory and company guidelines have been met and devices meet operational standards as designed.
• Perform visual, dimensional, and functional inspection of components and/or finished medical device products using a wide variety of tools and equipment to ensure conformance with design specifications. Highlight and escalate work issues to Lead
• Perform functional testing of finished medical device products using both automated and manual valve testing equipment
• Perform verification of quality records which include Device History Records review and/or product release for interplant shipment or distribution.
• May control inventory to ensure appropriate storage conditions and movement
• Other incidental duties: General work area housekeeping
Education and Experience:
Secondary Education Previous manufacturing and QC experience, Preferred
No previous related experience Required
• Basic computer skills, preferred
• Ability to read, comprehend, and speak English, and good communication skills, required
• Ability to use applicable tools and equipment, hand eye coordination, and high manual dexterity
• Basic level of understanding of inspection procedures
• Duties are clearly defined methods and tasks are described in detail
• Strict attention to detail
• Must be able to work in a team environment
• Ability to effectively provide and accept feedback from colleagues
• 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
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.