Compliance and Quality Specialist (CAPA)

Philips International; Taguig; On-site; PHP 700,000 - 1,200,000; Full time

Job summary

Philips in the Philippines seeks a Compliance and Quality Specialist (CAPA) to lead defect analysis, determine dispositions for non-conformances, and drive CAPA execution within the QMS. The role covers APAC regions and reports to the Senior Quality Manager - CAPA.

You will collaborate with internal and external partners, implement process improvements, and ensure regulatory compliance across medical devices and pharmaceuticals.

Qualifications

• Bachelor's degree in a science, engineering, or health-related field.
• Minimum 3+ years in Quality Assurance, Quality Control, Regulatory Affairs, CAPA, or Risk Management.
• Medical devices/pharmaceutical experience preferred; automotive backgrounds welcome.
• Understanding of ISO 13485, ISO 9001, ISO 14971 advantageous; FDA experience helpful.
• Excellent communication skills in writing and speaking.

Responsibilities

• Lead a group analyzing defects to determine dispositions of non-conformances.
• Facilitate CAPA and support Quality Management System improvements.
• Propose and implement enhancements to processes, tools, and systems.
• Build strong relationships with internal and external partners.
• Drive quality performance and regulatory compliance across APAC, Philippines, Vietnam, Thailand, Malaysia, Indonesia.

Skills

Communication

Stakeholder management

Independent work

Team player

Education

Bachelor's degree in science/engineering/health-related field

Tools

Excel

PowerPoint

Job description

Compliance and Quality Specialist (CAPA)

Job Family Summary: The Compliance Quality Engineering Team of the Quality Enterprise Services organization of Philips manages the quality engineering processes of the commercial operations including quality nonconforming investigations, equipment calibration issues, out-of-tolerance cases, and investigations of other nonconformities to support compliance, continuous improvement, patient safety, quality, and maintain our license to operate.

Responsibilities

In this role, the person will lead a group of individuals in the analysis of defects to determine dispositions of non-conformances and manage non-conformances Facilitate effective Corrective and Preventive Actions (CAPA) as well as support continuous improvement within the Quality Management System (QMS). Propose and implement enhancements to processes, tools, and systems as well as build strong relationships with internal and external partners Drive overall quality performance and operational excellence to ensure regulatory compliance through improvement initiatives This person will be supporting Asia Pacific - ANZ, Philippines, Vietnam, Thailand, Malaysia, and Indonesia (and other countries as needed by the business) This role is an Individual Contributor and will be reporting directly to the Senior Quality Manager - CAPA based in Puerto Rico.

Requirements

Bachelor's Degree in Any Science Degree (Physics, Chemistry, Biology, etc.), Engineering (with or w/o license), Health and Safety, Medical Technology, Pharmacy and/or Biomedical Engineering Minimum 3+ years working experience in Quality Assurance, Quality Control, Regulatory Affairs, CAPA, Supplier Quality and/or Risk Management Medical devices and/or pharmaceuticals experience is preferred but individuals from the automotive industry are welcome to apply Basic understanding of CAPA, as well as global medical device or pharmaceutical regulations, requirements; and standards such as ISO 13485, ISO 9001 and ISO 14971 (optional) is advantageous FDA experience is advantageous Excellent Communication Skills both in word and writing Strong Business understanding and ability to work independently and under pressure Highly Flexible in terms of work schedule Strong Stakeholder Management and Great Team Player Advance knowledge in Microsoft programs (Excel, PowerPoint, etc.)

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

About Philips

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters.

Equal Employment Opportunity

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights