Compliance and Quality Specialist (CAPA)
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What you'll do
- 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)
What they're looking for
- 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
- 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.)
Nice to have
- 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
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Title
Compliance and Quality Specialist (CAPA)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.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care.
Company
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