Quality Engineer

2 weeks ago

santa clara, United States Collabera Full time

The Senior Quality Engineer will play a critical role within the Regulatory Affairs (RA) organization, providing support to the RA team and business unit from a quality and compliance perspective. This role focuses on supporting audits, managing the CAPA process, and maintaining quality systems and compliance metrics through Key Performance Indicator (KPI) dashboards. The ideal candidate should possess a strong background in quality systems, have medical device experience, and be familiar with regulatory requirements. This is a strategic, senior-level role that requires initiative, problem-solving expertise, and effective cross-functional collaboration, including international interactions.


Key Responsibilities

  • Audit Support: Provide comprehensive support for audits within the Regulatory Affairs organization, ensuring readiness and compliance.
  • CAPA Management: Oversee and manage all CAPA activities for the RA team, identifying nonconformances, root causes, and corrective actions.
  • Quality Systems Compliance: Maintain and support the RA quality systems, ensuring adherence to medical device regulatory standards.
  • KPI Dashboard Management: Develop, monitor, and update KPI dashboards to track compliance metrics, identify potential risks, and implement mitigation plans to prevent audit findings or nonconforming results.
  • Process Improvement: Support the creation and management of quality processes that enable RA specialists to meet submission requirements.
  • Risk Management: Proactively identify compliance risks, communicate potential impacts, and put mitigation strategies in place to address these risks before they become audit findings.


Qualifications

  • Education: Bachelor’s degree required.
  • Experience: Minimum of 7+ years in quality systems, quality engineering, or regulatory affairs within the medical device industry.
  • Technical Knowledge: Strong familiarity with medical device regulatory requirements and standards, including CAPA and quality systems management.
  • Skills:
  • Independent and self-driven, with strong project management capabilities.
  • Excellent communication skills, capable of clear and effective cross-functional communication, including with international teams.
  • Strong problem-solving skills and ability to identify and mitigate risks proactively.
  • Proficiency with compliance and quality monitoring tools, KPI tracking, and data analysis.

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