QA Responsibility :
A. Documents Control
1) Assisting in managing quality document control system.
2) Preparing and revising Quality Procedures for process owner.
3) Preparing Document Change Notice.
4) Issuing document with identification of 'Master Copy', 'Controlled Copy', 'Uncontrolled Copy' and 'For
Training Purpose only'.
5) Updating and maintaining Document Master List and Records Master List and controlling the distribution of documents within the Quality & Regulatory Compliance Management System (QRCMS).
6) Maintaining Master Copy, Controlled Copy and Obsolete documents.
B. Technical Documentation
1) Assisting in composing and maintaining Technical Documentation in accordance with EU MDR 2017/745 requirements.
2) Liaising with OM to obtain latest Technical Documentation periodically.
C. Audits
1) Assisting in planning and coordinating Supplier / OM's periodic evaluation audit.
2) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.
3) Compiling and maintaining audit files.
D. Design and Development
1) Communicating with OM to assess the feasibility of new designs or changes in existing designs.
2) Coordinating with cross-functional teams including Sales and Marketing, QA / QC / RA, to align design and development project objective.
3) Preparing design plan and monitoring project timelines.
4) Preparing sample requisition form for design and development (SRD).
5) Organizing review meeting with team members on every design and development stages.
6) Conducting verification and validation on design and development product for compliance.
7) Completing and maintaining design and development files.
E. Artwork Verification
1) Checking, reviewing and verifying labelling of the device packaging to ensure compliance with customer requirement and Applicable Regulatory Requirements.
2) Liaising with supplier / designer / OM for artwork amendment and conversion.
3) Liaising with customer for artwork amendment and approval.
4) Compiling and maintaining Artwork File.
F. Others
1) Participating in Risk Management Team.
2) Assigning GS1 barcode number for new item / changed item.
3) Assigning lot number for legal manufacturer's product.
4) Performing other work related functions as assigned by superior
QC Responsibility :
1) Conducting inspection of incoming Raw Materials before dispatch for production.
2) Conducting inspection of Finished Products in accordance with documented procedures to conform to established specification before deliver to customer.
3) Completing and maintaining inspection activities' records for traceability purpose.
4) Identifying and segregating non-conforming material and product to prevent unintended use.
5) Reviewing and verifying Supplier / OM's Certificate of Analysis (COA) are conforming to the established specification before issuance of Certificate of Release (COR).
6) Issuing COR after reviewing of OM's COA for compliance.
7) Liaising with third party authority / laboratory for pre-shipment testing.
8) Reviewing and verifying external third party laboratory's testing report for compliance.
9) Reporting to QC Asst. Manager in the event of major variance in specifications / parameters.
10) Maintaining retained samples storage room in accordance with retention period.
11) Liaising with service provider to perform calibration of testing equipment.
12) Gathering and analyzing Quality Objective data for QC activities.
13) Participating in Internal Audits, Supplier / OM's periodic evaluation audit and External Audit.
14) Participating in Risk Management Team.
15) Performing other work related functions as assigned by superior.
