Compliance and Quality Specialist (CAPA)

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

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.

Your role/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

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose.
Learn more about our culture of impact with care.