Process Engineer
Summary
Process Engineer in a medical-device manufacturing environment, validating equipment, improving yields, and ensuring compliance with quality regulations.
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