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Senior QA/RA Manager

4 weeks ago

Dipolog, Philippines Michael Page Full time
  • A global leader in oral appliance therapy for obstructive sleep apnea.
  • Committed to producing high-quality, patient-matched medical devices.

About Our Client

With its Central Production Facility (CPF) in the Philippines, the organization is committed to producing high-quality, patient-matched medical devices that improve patient outcomes worldwide.

Job Description

Key Responsibilities:

Quality Management & Operations (≈90%)


  • Lead and enhance the Quality Management System (QMS) to ensure compliance with ISO 13485, CE marking, and other applicable standards.

  • Oversee QA processes, including SOP development, internal audits, deviation management, corrective and preventive actions (CAPA), and change controls.

  • Partner closely with production, R&D, supply chain, and global QA/RA teams to drive continuous improvement and operational excellence.

  • 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 (≈10%)

  • Maintain awareness and compliance with Philippine medical device regulations.

  • Liaise with local 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.

The Successful Applicant

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 FDA21 CFR 820 desirable.

  • Applied understanding of Philippine medical device 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 treatment for obstructive sleep apnea.

  • Lead impactful quality initiatives supporting patient health worldwide.

  • Join a culture rooted in integrity, innovation, teamwork, and respect.

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