Quality and Validation Engineer

2 weeks ago


Singapore CLEARLAB SG PTE. LTD. Full time

Responsibilities:

  • Initiate validation and qualification activities on new supplier, parts, processes and products as requested by related department to ensure compliance to QMS and business continuity.
  • Provide support to the revalidation and requalification activities of Engineering according to the Validation Master Plan to ensure compliance to QMS.
  • Create and execute protocol on stability studies for product shelf life and other engineering studies as required by business needs.
  • Review, update and maintain Risk Management Files and reports to ensure compliance to QMS and regulatory requirements.
  • Ensure smooth and effective operations in QA Incoming, IPQA, SFPI and Lot Release operations.
  • Ensure QA operations training program are properly implemented and QA nonexempt staffs competencies are evaluated on a yearly basis.
  • Manage the Control of Nonconforming Product System, and Customer Feedback System and ensure accurate investigations and effective feedback to customer complaints.
  • Support on the implementation and followup on CAPA and Process Change Control systems.
  • Support both internal and external audit activities of the company to ensure compliance to QMS.
  • Ensure smooth operations on Supplier Management Program (i.e. First Article submission, materials qualification, ShiptoStock Management, SCAR, etc.)

Requirements:

  • Minimum Degree in Engineering or equivalent.
  • At least 3 years quality or process engineering related experience in medical device industry with minimum 1 year experience in a supervisory role.
  • Familiar with cGMP.
  • Knowledgeable in Sampling Plan by Attributes.
  • Knowledgeable in Statistical Process Control.
  • Knowledgeable in Validation/Qualification processes.
  • Able to lead and manage special interest groups.
  • Fluent in written and spoken English.
  • Able to communicate and feedback clearly to superiors and other department's key person.
  • Able to perform GRR, DOE and process capability studies.
  • Strong technical writing skills.
  • Team player with good and positive working attitude.
  • Effective in decision making capabilities.
  • Meticulous in preparing reports, protocols and other documentation.


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