Senior QA/RA Manager

6 days 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.

#J-18808-Ljbffr

  • General Manager

    2 days ago

    Dipolog, Philippines Michael Page Full time

    A key distribution partner across several verticals An "agile market-access organization" committed to improving communities About Our Client The company has placed itself among the top 100 corporations in the Philippines, working with over 50 principal partners across both multinational and local brands. Its growth is driven by agile operations, efficient...

  • Lead Product Manager

    6 days ago

    Dipolog, Philippines Michael Page Full time

    Fully remote Be part of a growing industry and learn emerging technologies About Our Client This opportunity is with a large organization specializing in healthcare solutions. The company is committed to utilizing technology to enhance patient care and streamline healthcare processes, providing a robust environment for growth and innovation. Job...

  • Senior Application Data Developer

    6 days ago

    Dipolog, Philippines Michael Page Full time

    Be part of a team transforming healthcare technology. Advance in a company that values your skills and innovation. About Our Client The organization is a well-established large organization operating in the healthcare sector, focused on providing cutting-edge solutions and services. With a strong presence in the industry, it fosters a collaborative...

  • Sr. Recruitment Manager

    6 days ago

    Dipolog, Philippines Michael Page Full time

    Recruitment Leadership role in an strong PH Digital Bank Highly strategic and high-impact role within a growing business About Our Client A fast-growing digital bank with a strong approach to servicing the unbanked population of the Philippines. Globally recognized as a fintech to watch out for, given its world-class founding and leadership team. Job...

  • Digital Forensics

    6 days ago

    Dipolog, Philippines Michael Page Full time

    Join a pioneer team. Enjoy market-aligned salaries & benefits. About Our Client The organization is a leader in all-digital financial solutions. Job Description Oversees digital forensic investigations related to fraud, cybercrime, and internal threats, ensuring evidence integrity and regulatory compliance. Leads the collection, analysis, and...

  • Sr BD Manager

    6 days ago

    Dipolog, Philippines Michael Page Full time

    Join a global leader in health and security risk management. With operations in close to a 100 countries. About Our Client The company provides medical, security, and travel assistance services to organizations and individuals around the world. Their clients include multinational corporations, governments, NGOs, and educational institutions. Job...

  • Senior Product Manager

    3 weeks ago

    Dipolog City, Zamboanga Peninsula, Philippines Michael Page Full time

    A leading healthcare solutions company in Asia A multibillion-dollar business covering 17 markets About Our Client The company partners with more than 450 clients-including the top 20 pharmaceutical companies in the world-and serves over 200,000 medical facilities across the region. Job Description Key ResponsibilitiesDevelop and manage the annual...

  • Head of Key Accounts

    6 days ago

    Dipolog, Philippines Michael Page Full time

    International FMCG company Competitive compensation & benefits package About Our Client We are a globally recognized leader in the fast-moving consumer goods (FMCG) industry, known for our portfolio of trusted brands that reach millions of consumers every day. With a strong presence globally, we are committed to innovation, sustainability, and delivering...

  • Senior Application Developer

    3 weeks ago

    Dipolog City, Zamboanga Peninsula, Philippines Michael Page Full time

    Be part of a team transforming healthcare technology. Advance in a company that values your skills and innovation. About Our Client The hiring organization is a large organization within the healthcare industry, recognized for its focus on innovation and excellence in analytics. The company is committed to providing top-tier services and solutions,...

  • Head of Shopper Insights

    1 week ago

    Dipolog, Philippines Michael Page Full time

    Philippines leadership role Competitive compensation & benefits package About Our Client We are seeking an experienced Head of Shopper Insights to join our global FMCG company. This senior leadership role is pivotal in shaping the company's understanding of shopper behavior and driving business strategies that deliver measurable results. The ideal...