Global Medical Device Quality Leader

3 hours ago

Dipolog City, Zamboanga Peninsula, Philippines beBeeQuality Full time $40,000 - $65,000
Senior QA/RA Manager

  • Ensure quality excellence and compliance across global operations.

A global leader in medical device production is seeking a highly skilled Senior QA/RA Manager to lead the Quality Management System (QMS) and Regulatory Affairs functions.

The ideal candidate will have a strong background in QA/RA leadership, with experience in implementing ISO 13485 and MDSAP QMS. They will be responsible for managing quality processes, including SOP development, internal audits, deviation management, CAPA, and change controls.

Key Responsibilities:

  • Lead the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards.
  • Oversee QA processes, including SOP development, internal audits, deviation management, corrective and preventive actions (CAPA), and change controls.
  • Develop and deliver QA training to new and existing staff, building a strong quality culture.
  • Monitor, report, and act on Key Performance Indicators (KPIs) to maintain product quality and compliance.
  • Manage supplier quality, including auditing, incoming inspections, and nonconformance handling.
  • Support product development through design transfer, control of Device Master Records (DMR), and post-market surveillance.

Regulatory Affairs (Approximately 10%):

  • Maintain awareness and compliance with local regulations.
  • Liaise with regulatory authorities and external auditors as needed.
  • Support the preparation and maintenance of technical files and product documentation.

Leadership & Change Management:

  • Lead, mentor, and develop the QA team to ensure high performance and alignment with vision and values.
  • Guide the organization through change, fostering collaboration and continuous learning.
  • Promote a culture of integrity, customer focus, quality, teamwork, and innovation.

Health, Safety & Compliance:

  • Comply with Work Health and Safety (WHS) policies and proactively address workplace hazards.
  • Plan and assess potential impacts of organizational or process changes.
  • Report accidents, incidents, or hazards promptly to leadership.

Qualifications & Experience:

  • Bachelor's degree in a scientific discipline or related field; further certifications in QA/RA desirable.
  • At least 7 years' experience in QA/RA roles within medical device companies, including direct QA leadership.
  • Minimum 3 years in senior leadership roles managing large or cross-functional teams.
  • Strong working knowledge of ISO 13485 and MDSAP QMS; experience with US FDA 21 CFR 820 desirable.
  • Applied understanding of local regulations.
  • Experience with Class I and II / IIa medical devices.
  • Skilled in audit management, supplier quality, CAPA, and QMS documentation.
  • Proficient in Microsoft Office Suite; excellent communication and documentation skills.
  • Self-motivated, resourceful, and resilient in a fast-paced, global environment.
  • Demonstrated capability in transformation, customer centricity, innovation, and commitment to quality.

What's on Offer:

  • Work with a global leader advancing medical device production.
  • Lead impactful quality initiatives supporting patient health worldwide.
  • Join a culture rooted in integrity, innovation, teamwork, and respect.

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