Quality Engineer
1 week ago
Key Responsibilities:
Drive continuous improvement initiatives focused on enhancing process efficiency, product quality, and cost-effectiveness. Responsibilities include:
- Handling non-conformance (NC) reports from start to finish, including initiating, analyzing, investigating, reviewing, and closing reports.
- Collaborating with external suppliers to resolve NC issues efficiently.
- Conducting audits of internal processes and supplier facilities in compliance with ISO-13485 and/or 21CFR820 standards.
- Developing and implementing monitoring and control processes tailored to product risk levels.
- Collecting and analyzing data using various statistical and analytical methods to support ongoing improvements and daily operations.
- Leading investigations, documentation, and resolution of nonconformances, as well as managing Corrective and Preventive Actions (CAPAs) and customer complaints, escalating quality issues as necessary.
- Taking ownership of material identification and segregation processes, applying defect classification techniques effectively within manufacturing.
- Reviewing and analyzing preventive and corrective actions, and conducting root cause analysis following established procedures.
Note: This role may occasionally involve special projects beyond the listed responsibilities.
Preferred Qualifications:
- Education and Experience: Bachelor’s degree with a minimum of years of experience
- Demonstrated experience in a manufacturing or operational setting.
- Strong understanding of product and process risk management, particularly within FDA and ISO regulatory frameworks.
- Proven success in implementing risk mitigation strategies.
- Certification in ISO-13485 internal auditing is highly preferred.
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