Assembly Operations Specialist

hace 2 días


Paraíso, Paraíso, Costa Rica Edwards Lifesciences A tiempo completo

Job Overview

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We are seeking an Assembly Operations Specialist to join our team at Edwards Lifesciences. This individual will be responsible for assembling components used in the production of devices, ensuring compliance with regulatory and company guidelines.

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Key Responsibilities:

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The successful candidate will operate assigned equipment, demonstrate proficiency in various operations such as laser use, welding, knitting, autoclaving, kitting, ironing, and final packaging and labeling. Additionally, they will work on specific tasks such as sealer operation, in-process packaging, labeling, ID tag processing, washer use, ultrasonic cleaning, or oven operation to ensure appropriate settings and parameters.

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Responsibilities also include reviewing, following, and performing job functions in compliance with established work instructions and adherence to SOPs, GMPs, GDPs. The individual will record traceable information on device history records and may enter information into JDE.

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The Assembly Operations Specialist will perform line clearance, which involves cleaning and sanitizing workstations at the start of the shift and when transitioning to next work orders.

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Other key responsibilities include self-assessment of work, sequential review of colleagues' work, and providing constructive team feedback. The successful candidate must arrive on time, maintain regular attendance, and work a full 8-hour or longer work period.

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Requirements:

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To be successful in this role, candidates should possess a high school diploma or equivalent, along with 2 years of previous related experience. Previous GMP, clean room, and medical device experience are preferred.

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Skills and Qualifications:

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The ideal candidate will have knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices supporting a medical device environment. They must be able to use required hand tools, demonstrate hand-eye coordination, and possess high manual dexterity.

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Candidates should also be able to understand and follow complex work documentation with strict attention to detail, perform repairs on nonconformance errors, and possess good communication skills. Basic computer skills are required, as well as the ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures.

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Working Conditions:

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The Assembly Operations Specialist will work in a team environment, primarily with colleagues and supervisor. They must be able to work with minimum supervision by following detailed manufacturing instructions. The successful candidate will also be able to effectively provide and accept feedback from colleagues based on sequential work reviews.

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This role requires the ability to adhere to all company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and take adequate control measures to prevent injuries to themselves and others, as well as protect the environment and prevent pollution under their span of influence/control.



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