Job Description:
The Role of a Quality Assurance Associate is critical in ensuring that products, services, and processes meet established quality standards and regulatory requirements. This position serves as a guardian of quality, working to prevent defects, identify issues, and ensure compliance, ultimately contributing to customer satisfaction and regulatory adherence.
Key Responsibilities:
1. Adhere to quality procedures and specifications, guaranteeing the highest level of product quality.
2. Coordinate the collection and packing of customer samples with precision and care.
3. Ensure retain samples are properly stored and logged for all medical batches, maintaining accurate records for future reference.
4. Monitor production closely, highlighting and resolving non-adherence to quality procedures and specifications promptly.
5. Collaborate with colleagues to resolve quality-related issues in production, ensuring issues are documented correctly and thoroughly.
6. Participate in team investigations for customer complaints as requested, providing valuable insights and expertise.
7. Conduct product audits to ensure compliance with established quality standards.
8. Complete First Piece, In-process, and Certificate of Analysis (COA) for medical, industrial, and automotive products as required, maintaining accuracy and attention to detail.
9. Issue batch documentation, including data record sheets, labels, etc., to production at the start-up of medical batches, ensuring seamless communication and coordination.
10. Perform product inspections where required, upholding the highest standards of quality control.
11. Complete product measurements, including DOE, for validation purposes, applying technical expertise and analytical skills.
12. Train production operators to ensure understanding of relevant specifications and procedures, promoting knowledge sharing and skill development.
Key Relationships:
- Quality Assurance Personnel: Collaborate within the Quality Team, fostering a culture of collaboration and open communication.
- Operations Leads / Production Manager: Liaise on Quality issues, ensuring alignment and mutual understanding.
- Production Personnel: Receive training on product quality requirements and procedures, empowering employees with the knowledge needed to excel.
- Engineering Department: Coordinate on Quality issues, leveraging expertise and resources to drive continuous improvement.
Decision Making:
Quality Associates have the authority to place products on hold, exercising sound judgment and discretion when necessary. A decision to stop production can be made in conjunction with the Operations lead, promoting effective problem-solving and swift action.