Job 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.

As a Quality Inspector you will assess devices in-process and upon completion, revies accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed.

Working Hours: 4 Day Week, Monday to Wednesday (4:30PM-3AM), Thursday (4:30PM-2AM)

Key Responsibilities:

• Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements

• Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications

• Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards

• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks

• Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction

• Perform line clearance and verification of inspection

• Perform verification of manufacturing documents with component and device drawings

• Support the training of other inspectors through work demonstration and feedback

• May ensure smooth shift transitions by providing status de-brief of shift activities

• Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc.

• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period

• Other incidental duties: General work area housekeeping

Education and Experience:

• 2 years of previous related experience, including GMP and GDP Required

• Leaving Certificate or equivalent Preferred

Additional Skills:

• Good communication skills

• Able to read, comprehend, speak, and write English

• Basic computer skills, required, including 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

• Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity

• Full understanding of applicable inspection procedures

• Continuously expands proficiency in inspection techniques

• Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System)

• Must be able to work in a team environment and with minimum supervision by following detailed work instructions

• 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