CAPA Owner

Philips International; Pune District; On-site; INR 1,800,000 - 3,200,000; Full time

Benefits offered by this job

Global exposure

Medical device industry experience

Job summary

Philips - CAPA Owner role focusing on developing and validating electrical systems for Interventional Guided Therapy. Lead CAPA investigations, drive root cause analysis, and ensure timely closure with robust action plans.

You will coordinate across India and Europe, maintaining CAPA records in the QCM tool and aligning with quality standards. This senior position demands 14+ years of engineering experience, strong CAPA and ISO13485 familiarity, and excellent communication.

Qualifications

• Engineering degree in a mechanical/electrical/electronics/mechatronics field.
• 14+ years of professional engineering experience.
• 5+ years in medical device quality management systems (ISO13485).
• 5+ years in CAPA and regulated industry environments.
• Strong English communication and teamwork skills.

Responsibilities

• Independently execute CAPA from ownership acceptance to closure.
• Lead and coordinate CAPA investigations with cross-functional teams.
• Develop CAPA plans for optimized resource use and timely delivery.
• Ensure objective evidence supports investigation findings and actions.
• Maintain CAPA documentation in the Quality Case Management tool.
• Communicate CAPA progress to stakeholders in India and Europe.

Skills

Leadership

Quality management

CAPA process

Education

Engineering degree in Mechanical/Electrical/Electronics/Mechatronics

Tools

Quality Case Management (QCM) tool

Job description

Job Title CAPA Owner Job Description

In this role, you have the opportunity to develop electrical (sub-) systems and solutions (including their validation, testing and troubleshooting) for Interventional Guided Therapy systems (fixed interventional X-Ray systems). You will work within a multi-disciplinary team on applying research results and technology advancements to improve and release new advancements of Philips IGT Systems. Our system need to fulfill all applicable international standards.

You are responsible for Primarily responsible and accountable to Independently execute a CAPA from Ownership acceptance until closure. You will be the leading the team of subject matter experts driving multiple CAPA investigations collaborating across functions. Responsible for ensuring the CAPA deliverables and timelines are resources and met. Creates the CAPA plan to optimum utilization of CAPA resources to solve complex and critical issues. Align on Team Way of Working: Best practice is to treat the Investigation phase similar to a workshop / kaizen. Leads the progress for the assigned CAPA for the robust and quicker solutions. Use of best approach for key deliverables such as root cause investigations Ensures the investigation is supported with objective evidence and supporting records and an aligned accepted action plan. Meet all the Quality standards for CAPA Execution Maintain the documents of CAPA into Quality Case Management (QCM) tool. Communicate the progress of CAPA to all the relevant stakeholders Clear communication and successful cooperation with your colleagues in India and Europe, or any other part of world. Co-creating, maintaining and carry out the CAPA team vision / mission / strategy Co-create, maintain, and improve your facilities (labs, equipment, quality of own and suppliers) Successful cooperation with your internal / external customers You are a part of CAPA Team - Pune Department within the Mechatronics Development Cluster of R&D IGT Systems in Best, Netherlands.

To succeed in this role, you should have the following skills and experience

• An Engineering degree in Mechanical/Electrical/Electronics/Mechatronics or related discipline.
• a minimum of 14+ years of relevant experience in professional engineering environment
• a minimum of 5 years’ experience in Quality management systems of Medical devices (preferable in ISO13485:2016)
• a minimum of 5 years’ experience in development (preferable experience in IEC60601-1)
• Work experience of Handling the CAPA into regulated industry
• Experience of maintaining the Quality Case Management (QCM) tool
• Understanding of CAPA process, key steps, and criteria for success
• Experience of problem solving techniques and tools
• a minimum of 5 years’ experience in equipment, labs, and facilitation & requirement definition
• Experience in new product introduction or life‑cycle development in the industry
• Being a team player with good managerial skills (soft skills)
• Good communication skills in English
• Drive for quality and continues improvement
• Team engagement

In return, we offer you with the opportunity to expand your professional experience. In our competence areas, we can offer you stimulating challenges across a wide range of application domains, interesting variation, job satisfaction and the chance to broaden your experience – all within one company. The opportunity to shape and grow your career will be in your own hands.

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 improving 2.5 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. To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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.

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