Edwards Lifesciences Associate Machine Operator (3rd shift) in Anasco, Puerto Rico
Applies skill and dexterity in the operation of a variety of types of machinery in the manufacturing process, in keeping with regulatory and company guidelines.
Set up and calibrate equipment and machinery; an operate one of a variety of equipment – housing, injection molding, form fill and seal flow tester packaging machinery, etc – in the manufacturing process of medical devices, including equipment set-up and adjustments throughout the production process to ensure appropriate settings and parameters to achieve product design and quality specifications, while maintaining a stable and effective process.
Select and utilize the associated equipment manufacturing fixtures/aids – cutting dies, flexographic plates, or any other required fixture associated with assigned operation/task.
Review, follow and perform job functions in compliance with work instructions and adherence with SOPs, including recording traceable information on device history records and enter information into JDE.
Perform inspections of machinery and output to ensure the processes are being executed in conformance with production specifications, including using measurement devices to ensure seal widths are in compliance.
Ensure automated recording of parameters.
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, providing defect-free documentation.
Education and Experience:
H.S. Diploma or equivalent and no previous related experience, required.
Some previous experience in using similar machinery, preferred.
Availability to work rotating shifts, holidays and weekends, as per business needed.
Ability to use a variety of manufacturing equipment and fixtures.
Basic level of understanding of manufacturing procedures.
Basic computer skills, preferred.
Good communication skills.
Open to receiving and giving team performance feedback.
Able to read and comprehend English.
Knowledge of and adherence 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 departmental colleagues and supervisor.
Strict attention to detail.
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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