Acting CAPA Manager you will be primarily responsible for the oversight of the CAPA process and related procedures and tools in International Markets. You will ensure CAPA process is compliant, effective and efficient in dealing with quality issues. As CAPA Manager (without direct reports) you will, through expertise in problem solving methodology, facilitate proactive and effective resolution of issues, and drive continuous improvements within International Markets.
You are responsible for
Acting as International Markets CAPA Subject Matter Expert (SME) and primary point of contact on all CAPA related procedures and tools, ensuring compliance to the relevant Global procedures.
Support Market/Market enabling function CAPA owners in the effective execution and timely closure of CAPAs through performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
Lead & execute the CAPA review board forum, oversee CAPA extension requests and review/response to CAPA requests.
Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
As CAPA SME, International Markets, provide input to International and Multi-Market forums (e.g. Management Review, Monthly Q Ops, Q Planning, Multimarket CAPA Center of Excellence)
Drive continuous improvement, and contribute in developing optimum future state of the CAPA process for Markets needs, aligned with Global PQMS
Super user of eCAPA system (Trackwise). Ensuring users provide the necessary rigor to the eCAPA system content including maintaining a live document with all relevant evidence attached, in a timely manner.
Ensure adequate training is developed, maintained and provided to all users of CAPA process & systems. Promote the use of Philips Problem solving techniques (Kaisen/PRIDE)
Act as CAPA SME in support of preparation, participation and follow up to Internal and third party audits.
You are a part of
International Markets Q&R Team, consisting of PQMS Team (operating the Multimarket Philips Quality Management System (QMS)), and International Market Q&R leaders.
Key partner to Global PQMS team, NAM & Gr China Markets, Services & Solutions Q&R team and Philips PEPF BPO/BPEs.
To succeed in this role, you should have the following skills and experience
A person who is excited by the unique professional challenges that our International markets presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a CAPA SME who will continuously strives for excellence as a way of life; not just as a job. Were looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people Philips brand touches each year.
Bachelor/Master degree in an engineering or scientific-related field or equivalent technical experience
At least 6 years of experience in a regulated environment (a couple of which in medical device), having 2 years with direct CAPA QMS element responsibility.
Strong understanding of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
Able to understand and analyze complex problems, including software and hardware design issues.
Ability to assess risk as it pertains to the CAPA process.
Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
Demonstrated ability to partner with the Markets, Market enabling functions and business, and effectively interact with and influence employees, and managers on all levels in a matrix organization.
Strong Project Management skills.
Ability to analyze data and apply statistical techniques.
Excellent written and verbal communication skills
10% travel may be required.
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
Why should you join Philips?
Working at Philips is more than a job. Its a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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