- Paya Lebar Road Geylang Southeast (Singapore) Singapore
工作地点
职位描述
岗位职责
Job Responsibilities:
Prepare and execute all assigned validation / re-validation protocol and engineering study protocol.
Monitor and in-charge of the machines / systems validation / re-validation status.
Monitor machine performance to ensure good quality and yield results.
Improve process performance to sustain product quality and quantity.
Ensure calibration compliance at all times to comply with QSR (Quality System Regulation) requirement.
Documentation and preparation for monthly / bi-yearly and annually calibration of requirement and tools.
Qualify / re-certify the sterilizers used for production annually.
Investigate manufacturing issues, non-conformances, and customer/internal complaints.
Assess, initiate and implement engineering change requests (ECR/ECO).
Provide technical troubleshooting support for manufacturing equipment and processes.
Perform risk assessments on equipment, processes and changes.
Support internal, customer and regulatory audits.
Review, create and maintain engineering documents, SOPs, OIs, protocols and reports.
Support new product introduction and process transfer activities.
Support all other engineering team and other department in terms of project, yield improvement, validation activity, troubleshooting and engineering study.
Requirements:
Diploma or Degree in any Engineering field.
Minimum 2 years of experience in medical device manufacturing environment as process engineering role.
Knowledge in mechanical and/or electrical.
Strong communication skills, both verbal and written.
Ability to work under pressure.
Effective team player
CLEARLAB SG PTE. LTD.
Clearlab is the manufacturer of the world’s first biocompatible daily disposable contact lens, with the main manufacturing site in Singapore and Korea. We are committed to delivering innovative contact lens products and services to the global marketplace, while maintaining exclusivity and profitability to all of our customers. At Clearlab, product quality and customer satisfaction are our utmost priorities.
We offer a broad range of lens materials and modalities. Our product portfolio includes daily disposables, biweekly and monthly frequent replacement lenses, and a full line of cosmetic color lenses. Clearlab also offers customised toric lenses with precise optics to meet diverse consumer demands.
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