CAPA Facilitator

Philips International; Bengaluru; Hybrid; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Hybrid work model

Equal employment opportunity employer

Job summary

Philips in Bengaluru is seeking a CAPA Facilitator to drive CAPA processes, lead complex investigations, and mentor cross-functional teams within the Quality & Regulatory group. The role demands robust statistical and problem-solving skills to ensure effective CAPA implementation and audit readiness.

The position offers a hybrid work model with three days in office and two from home, and requires a Bachelor's/Master's in Engineering or related field with 8–10 years in Medtech quality roles.

Qualifications

• Bachelor's/Master's degree in Engineering or related field; statistics or quality management an advantage.
• Minimum 8-10 years of quality experience in Medtech industry.
• Knowledge of 21 CFR Parts 803, 806, 820; ISO 13485; ISO 14971.
• Strong facilitation, cross-functional coaching and data analysis skills.

Responsibilities

• Support CAPA from issue identification to closure and ensure CAPA content quality.
• Assess complex investigations and corrective actions; review data and lead root cause analysis.
• Facilitate CAPA investigations and ensure cross-functional commitment and timely deliverables.
• Support CAPA Owners and present CAPAs during audits and CAPA Review Board meetings.
• Mentor teams in root-cause analysis methods and in interpreting quality monitoring data.

Skills

CAPA leadership

Root cause analysis

Cross-functional coaching

Statistical methods

Quality systems knowledge

Education

Bachelor's/Master's in Engineering or related field

Tools

LEAN, DMAIC tools

Job description

Job Title CAPA Facilitator Job Description Job Title: CAPA Facilitator Job Description Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. In this role, you have the opportunity to make life better Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

You will support the Corrective and Preventive Action (CAPA) process from issue identification to closure and ensuring adequate execution of process and the quality of CAPA record content.

You are responsible for Supporting CAPA activities: assessing complex investigations and corrective actions, reviewing test and other complex performance data, leading complex root cause analysis and quality problem solving Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring Support CAPA Owner in all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines Support CAPA Owners in the presentation of CAPAs during audits and CAPA Review Board meetings Mentor cross functional teams with the implementation of appropriate root cause analysis techniques Mentor the analyze of quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances

You are a part of Our Quality & Regulatory organization, supporting Image Guided Therapy Systems.

To succeed in this role, you’ll need a customer-first attitude and the following Bacheor's/Master's degree in Engineering or other relevant academic field as statistics, quality management, etc., advanced degrees – an advantage Minimum 8-10 years experience in quality roles in Medtech industry Knowledge of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971 Good understanding of statistical methods, quality tools, problem solving tools and methodologies (i.e. 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) Experience as team facilitator / team coach Work experience organizations with Manufacturing, R&D and Engineering environments Strong communication and interpersonal skills, ability to coach teams in matrix environment cross-functional teams, accurate, able to work under pressure. Ability to resolve complex issues in creative ways and influence stakeholders accordingly Multi-tasking and decision-making capabilities

In return, we offer you We welcome you to a challenging, innovative environment with great opportunities for you to explore.

How we work at Philips Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving. We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. #LI At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace. Know Your Rights