Quality Assurance Technician

1. Scope of the position

Quality Assurance – Representing the Customer at Mergon International

2. Key Responsibility

• Adhere to quality procedures and specifications.
• Coordinate the collection and packing of customer samples.
• Ensure retain samples are kept and logged for all medical batches.
• Responsibility to monitor production, highlight and resolve nonadherence to quality procedures and specifications.
• Assist in resolving quality related issues in production (screening of product / decision on product), ensuring issues are documented correctly.
• Partake in team investigations for non-conformances and CAPA’s, as requested.
• Partake in team investigations for customer complaints as requested.
• Carry out product audits.
• Complete First Piece, In process and Certificate of Analysis (COA’s) for medical, and as required for industrial and automotive products
• Issue batch documentation including data record sheets (First Piece, In Process), labels, etc to production upon start-up of medical batches.
• Perform product inspection where required.
• Complete product measurements including DOE, for validation purposes.
• Carry out production operator training to ensure that operators understand all relevant specification and procedures.
• Carry out ongoing training with quality associates to ensure they fully understand all relevant specifications and procedures.

3. Key Relationships

Quality Assurance Personnel: To work as part of the Quality Team and assist with the training of quality associates.

Ops leads / Production Manager: To liaise on Quality issues.

Production Personnel: Training on product Quality requirements & procedures. Engineering Department: To liaise on Quality Issues.

4. Decision making authority

Quality Technicians have the Authority to place Product on-hold. A decision to stop Production can be made in conjunction with the Ops lead.

The above is not exhaustive. Other duties and responsibilities may be added as the employee’s immediate supervisor deems appropriate.