Senior QA/RA Manager - Manila

• 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.

• 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.

• 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.

• 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.

A global leader in oral appliance therapy for obstructive sleep apnea. Committed to producing high-quality, patient-matched medical devices.

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.

• 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.