What are the responsibilities and job description for the Quality Assurance Specialist position at Integration International Inc.?
Job Title: Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to support and enhance our product quality throughout its lifecycle.
This is an exciting opportunity to contribute to a high-quality product lifecycle and play a key role in ensuring excellence.
Key Responsibilities:
- Lead continuous improvement actions to enhance product quality.
- Collaborate with Engineering and Manufacturing to define acceptance criteria for production processes.
- Investigate product issues, conduct root cause analysis, and implement corrective actions.
- Analyze production quality data to identify trends and initiate corrective actions.
- Support external audits and provide responses to customer inquiries regarding quality assurance.
Required Skills and Experience:
- Bachelor's Degree in Engineering or related field.
- 3 years of experience in quality assurance or a related role.
- Strong understanding of ISO 13485, ISO 9001, or similar formal quality systems.
- Familiarity with FDA-regulated environments and lifecycle risk management (e.g., ISO 14971).
- Strong verbal and written communication skills.