Quality Assurance Engineer

Job Description:

The Quality Assurance Engineer is responsible to ensure that production processes remain in a state of control, validation and verification activities are robust, and processes consistently produce medical devices that meet specifications. This role supports and ensures compliant execution of New Product Introduction and manufacturing Life Cycle Management activities and drive continuous improvement activities.

Accountabilities

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.
  

Job Requirements:

• Ensure process risk assessment files are in accordance with ISO 14971.
• Ensure validations and verifications are robust, monitoring activities are performed and analyzed and oversee revalidation cycles.
• Ensure manufacturing-related procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Monitor and track non-conformances, and lead continuous improvement projects.
• Act as a consultant for project teams and individuals related to application and interpretation of internal and external procedures, guidance, standards and regulation to find pragmatic ways to achieve appropriate and compliant documentation of activities.
• Participate in NPI and Lifecycle projects to ensure compliant execution thereof.
• Document and evaluate production non-conformances, and drive root cause analysis.
• Support critical and time-sensitive topics, such as recalls, production issues, internal and external audits, corrective and preventive action (in different roles)
• Support the creation, implementation, training and continuous improvement of Quality Assurance processes.

Operating Company:

Nobel Biocare

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