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:

• Critical Knowledge and Qualifications:
  • Higher education (bachelor or master degree) in engineering or lifescience discipline
  • In-depth understanding and knowledge on standards and regulation including but not limited to:
    • ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
    • ISO 14971 - Medical devices - Application of risk management to medical devices
    • IEC 60812 - Failure modes and effects analysis (FMEA and FMECA)
    • 21 CFR 820 QMSR - Quality Management System Regulation (FDA)
• Critical Skills/technical know-how:
  • Exercises independent work style and judgment in complex quality and compliance topics
  • Applies risk-based thinking
  • Communicates effectively (verbal and written) across functions
  • Strong analytical, statistical, and documentation capabilities
  • Fluent English and Swedish
• Critical Experience:
  • Minimum of 6 years of quality engineering experience in the medical device industry or equivalent regulated industry in a manufacturing environment.
  • Hands-on expertise in root cause analysis tools (5-Why, Fishbone),

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Operating Company:
Nobel Biocare
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