Edwards Lifesciences Associate Assembler (3rd shift) in Anasco, Puerto Rico
Applies skill and dexterity in the assembly of components into finished devices, in keeping with regulatory and company guidelines.
Use tools and equipment - which may include one or more of the following welders, solders, ovens, autoclaves, microscopes, magnifiers, scissors, knives, or others - for assembly and packaging/labeling in the manufacturing process of medical device components.
Self-assessment of work, which may include visual inspection under a microscope, and sequential review of colleagues work, providing constructive team feedback, based on SOPs and quality guidelines; including escalating work issues and changes in equipment performance to supervisor for assessment and correction, including reworking units as required.
Assure appropriate settings and parameters of equipment for precise assembly and inspection of medical devices, in a timely fashion at each work station, following work order instructions and drawings, using computers to navigate drawings, and entering parts status data.
Inventory reconciliation at start of day and when transitioning to next work order.
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 may enter information into JDE.
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, attend trainings, meetings, special assignments and other miscellaneous tasks, perform other duties as assigned by Supervisor.
Education and Experience:
H.S. Diploma or equivalent, no previous related experience, required.
Experience working in a manufacturing environment, preferred.
Availability to work rotating shifts, holidays and weekends, as per business needed.
Basic level of understanding of manufacturing procedures with proficient in assigned operations for a given model.
Proven ability to complete, retain, and incorporate training coursework in the performance of new and advanced work procedures.
Good communication skills.
Able to read and comprehend English sufficiently to determine system work order status.
Basic computer and mathematics skill.
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 by following detailed manufacturing instructions.
Work in a Team environment, primarily with colleagues and supervisor
Flexibility to work overtime and varying shifts.
Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory.
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.
Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 or have a valid religious or medical exemption from being vaccinated.
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