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CORCYM is a global, independent, medical device company entirely focused on state-of-the-art surgical solutions to fight structural heart disease. CORCYM has a presence in more than 100 countries with approximately 850 employees and ensures strong continuous support to patients, healthcare professionals and healthcare systems worldwide.

WHO WE ARE:

Corcym offers a complete portfolio of surgical solutions with a heritage spanning more than 50 years, leveraging on a complete and distinctive set of technologies, capabilities and infrastructure.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Able to do repetitive detailed work within guidelines and maintaining precise records.
• Be able to lift and transfer 8 to 10 L carboy/s to the working area
• Good time-management skills and ability to multi-task.
• Has basic mechanical aptitude. Able to to operate theBranson cleaning machine Leaflet Formation, Meile parts washer and use all the applicable tooling in the production area.
• Demonstrate the ability to perform tasks with extreme detail, accuracy and speed.
• Good time-management skills and ability to multi-task. Demonstrates an appropriate sense of urgency, complies with scheduling requirements and ensures prompt product movement.
• Able to read and understand instructions, policies and procedures written in English.
• Capable of giving detailed verbal instructions and feedback in English.
• Is open-minded and accepts constructive criticism and feedback.Able to work well with co-workers in a team environment.

EDUCATION & EXPERIENCE:

• High School Diploma or equivalent
• 2 years of experience in heart valve manufacturing environment or a GMP production environment.
  Working Conditions: (Physical Demands/Environmental Factors)

% of Job: Rarely (<2%), Occasional (3-33%), Frequent (34-66%), Constant (67-100%)

• Work in a controlled and uncontrolled environment requiring special garments, gloves, masks, etc which can be confining. - Constant
• Frequent use of safety equipment (i.e. goggles and respirators). - Occasional /Frequent
• May require rotating day shift and afternoon shift and work overtime hours on short notice.- Occasional
• Usage and handling of (caustic) chemicals, which could be harmful if proper safety precautions are not followed.
• In a clean room for extended periods. - Frequent
• May require rotating day shift and afternoon shift. – Constant
• Work overtime hours on short notice. - Occasional
• Training wage starts at $20/hour. Upon successful completion of clinical training, wage will be increased to $21/hour

• Prepare solutions and operate the Branson cleaning machine to perform ultrasonic cleaning of final device components. Perform manual cleaning of components as required
• Perform cleaning and verification of nitinol stents.
• Perform cutting, inspection, and cleaning of serial tags.
• Perform teardown of the tissue component of a Perceval valve, and the recovery and rinsing of the nitinol stent to facilitate stent re-use.
• Perform valve load-in, load-out from Leaflet Formation machine.
• Perform bio-burden reduction process on Perceval valves.
• Perform valve sharping steps on Lancelot valves.
• Clean and sanitize the machines using glutaraldehyde and minncare solutions as specified.
• Perform cleaning and sanitization of machine accessories and other production tools (ex. mandrels, discs, shaping tools, sewing templates)
• Prepare DI water as required.
• Perform holder attachment and insert application to valve sub-assemblies according to production plan.
• Monitor and maintain solution change requirement for all valves within specification.
• Perform Process Tube Load-in for valves to prepare for sterilization according to production plan.
• Perform Final Packaging tasks and re-packaging of all models of valves with the correct configuration.
• Perform visual, dimensional, functional, and mechanical inspections as trained and required of packaging materials and labels.
• Operate and clean glutaraldehyde distillation equipment to meet production demand.
• document work accurately and completely in MES, Business System, forms, or logbooks/daily production logs as applicable to the task and minimize errors that result in Non Conformance Reports (NCR), Failures in Process (FIPs).
• Assure labour tracking time systems are accurately maintained.
• Performs process verification at various stages.
• Maintains traceability and proper documentation on all materials and components processed through the area.
• Assures equipment has been calibrated prior to use and is properly secured upon completion.
• Performs daily monitoring of equipment and environment as required.
• Handles chemicals as required after proper training by wearing appropriate personal protective equipment for task being performed and adhering to all safety procedures & regulations
• Follows 6S initiatives by maintaining inventory of materials in their respective area
• Organizes storage of components and supplies.
• Performs cleaning of critical controlled areas, gowning rooms and uncontrolled areas in accordance with established procedures.
• Collaborates with assigned trainees and Supervisor to adjust training plan as needed to ensure golas are met.
• Offers feedback to co-workers/trainees in a manner that promotes teamwork and collaboration.
• Offers opinions and ideas to help improve processes and procedures.
• Reports problems and potential problems to lead or area supervisor.
• Perform other duties as required.