Quality Engineer

The QA Operations shall have a responsibility that includes:

• Supports manufacturing and operation with establishment and maintenance of testing and inspection processes.

• Identifies improvements and inputs into the quality planning process.

• Reviews, revises and approves documentation for consistency and compliance with good documentation practices, QMS and regulatory requirements.

• Supports Document Control process and engineering changes

• Manage the core QMS processes such as: Non-Conformities (NCs), Failures analysis, Corrective And Preventive Action (CAPA) and SCAR processes.

• Responsible for Suppliers' quality issues.

• Participates in continuous quality improvement efforts through the evaluation of trends in key performance indicators, audits, and corrective/preventative actions.

Requirements

• Bachelor’s degree in engineering or closely related field,

• 3-5 years' experience in a manufacturing environment and Supplier Quality in medical device industry, including in depth knowledge of ISO13485 .

• Strong knowledge of the FDA and EU medical device regulations, standards and guidance document.

• Proven experience in establishing procedures for maintaining high standards of product quality and reliability.

• Decisions made with in-depth understanding and interpretation of procedures, policies and business practices to achieve results.