QMS and MS Manager

Job Title

Job Description

Job Title : QMS and MS Manager

Job Responsibilities:

• Takes ownership of the Document and Change Control activities and training activities for the Personal Health Management System

• Supports the Document and Change Control activities of the Personal Health Quality Management System by contributing to the development implementation and revision of MS-QMS processes including standard operating procedures (SOPs) and work instructions ensuring their accuracy clarity and compliance with relevant standards.

• Leads and or supports PH Regions and PH CoEs QMS relevant activities and projects.

• Responsible for the translation of Management System and Quality Management System content.

• Leads cross-functional problem-solving sessions to address significant QMS issues utilizing structured methodologies like root cause analysis and driving the implementation of solutions.

• Prepares for and participates in internal and external regulatory audits and inspections within Personal Health Business Units and Regions by ensuring readiness of documentation processes and records facilitation of audits and provide responses to audit findings in collaboration with stakeholders.

• Works under limited supervision and broad guidelines regularly applying independent judgment on matters of significance to drive project success and compliance.

• Conducts risk assessments activities identifying potential risks to regulatory compliance quality and QMS integrity and developing robust mitigation strategies to minimize their impact.

• Participates in continuous improvement initiatives within the QMS proposing and implementing enhancements to processes tools and systems to drive overall quality performance and operational excellence.

• Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team ensuring effective solutions and innovative approaches to complex challenges.

• Participates in training sessions to stay updated on quality standards and QMS procedures actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.

• Cultivates effective relationships with internal and external partners providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.

Minimum required Education:
Bachelors / Masters Degree in Mechanical Engineering Industrial Engineering Science or equivalent.

Minimum required Experience:
Minimum 10-12 years of experience with Bachelors in areas such as Quality Management Systems Quality Audits or equivalent in highly regulated environments/industries such as Medtech Pharma or Automotive

Preferred Skills:
Regulatory Requirements and compliance (ISO 9001 ISO 13485 QSR/QMSR) - mandatory
Quality Management Systems (QMS) - Mandatory
Project Management
Troubleshooting
KPI Monitoring and Reporting
Data Analysis & Interpretation
Process Improvements
Technical Writing
User Training & Support
Training Content Development
Business Acumen

About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.

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

Our commitment to inclusion and diversity

At Philips we provide equal opportunities to all our employees and to all eligible applicants for employment in our company irrespective of age color disability nationality race religion gender sexual orientation (LGBTQ ) and all aspects that make individuals unique. Encouraging diversity and fostering inclusion are key to our mission of improving the lives of 2.5 billion people a year by 2030 through meaningful innovation. We have fair transparent and clear employee policies which promote diversity and equality in accordance with currently applicable we believe that life is better when #youareyou.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: Theres a certain energy when everyones 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 isnt 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. Its 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