Quality and Validation Engineer

7 days 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 non-exempt staffs competencies are evaluated on a yearly basis.
- Manage the Control of Non-conforming Product System, and Customer Feedback System and ensure accurate investigations and effective feedback to customer complaints.
- Support on the implementation and follow-up 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, Ship-to-Stock 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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