Global CAPA & Quality Compliance Specialist

Philips Philippines Inc; Pateros; On-site; PHP 600,000 - 1,000,000; Full time

Job summary

Philips Philippines Inc. is seeking a Compliance and Quality Specialist (CAPA) to lead a team in analyzing defects, managing non-conformances, and driving CAPA within the QMS across APAC regions, including Philippines, Vietnam, Thailand, Malaysia and Indonesia.

Reporting to the Senior Quality Manager - CAPA based in Puerto Rico, you will promote process improvements, strengthen internal and external partnerships, and ensure regulatory compliance with ISO 13485/9001, FDA considerations, and

Qualifications

• 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.)

Responsibilities

• 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)

Skills

CAPA

Quality Assurance

Regulatory Affairs

Stakeholder Management

Communication Skills

MS Office

Education

Bachelor’s degree in science/engineering or related fields

Tools

Excel

PowerPoint

Job description

Philips Philippines Inc. is seeking a Compliance and Quality Specialist (CAPA) to lead a team in analyzing defects, managing non-conformances, and driving CAPA within the QMS across APAC regions, including Philippines, Vietnam, Thailand, Malaysia and Indonesia.

Reporting to the Senior Quality Manager - CAPA based in Puerto Rico, you will promote process improvements, strengthen internal and external partnerships, and ensure regulatory compliance with ISO 13485/9001, FDA considerations, and