You are responsible for
Assures compliance to applicable local and international
regulations / standards and Philips requirements.
Organize and facilitate the external audits
Manage and facilitate the internal audit program
Challenge the CAPA and IA owners for improvement on systemic issues.
Train and coach people on the CAPA, DPIA, NCR process and other QA deliverables.
Defines, establishes, monitors & improves training on key compliance topics.
Participates in Quality & Regulatory initiatives as a cross functional
Use Data Mining techniques and automated analytical tools to extract data from complex systems, analyze company-wide operational
information and identify trends / metrics.
Compile and communicate operational information, including metrics and
significant trends, to management and other stakeholders.
Perform analyses and continuous monitoring in support of internal audits, management reviews,
consulting requests and external audits.
Assists organizational units in addressing compliance deficiencies.
You are a part of
A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree,or a combination of equivalent job experience in related field.
Current certification with a recognized Accreditation body (i.e.,
RAB-QSA / IRCA) or successful completion of ASQ certification as a
Certified Quality Auditor (CQA) and / or Certified Biomedical Auditor
Successful completion of a recognized Lead Auditor course, it's a plus.
MDSAP Model understanding.
QA system software configuration and administration experience / education.
5+ years of experience in a medical device,biologics or Pharma industry.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Part 820, ISO13485, ISO14971, European Medical Device Directive (93 / 42 / EEC), EUMDR, Canadian Medical Devices Regulation (SOR / 98-282), Japanese MHLW Ordinance 169, and ISO 9001.
Strong CAPA knowledge and experience.
Advanced English Level.