QMS Manager

1 month ago

Bengaluru, India Philips Full time
JOB DESCRIPTION

Job Title

QMS Manager

Job Description

Job Title : QMS Manager

Maintains, enforces, and manages a compliant and effective QMS for the activities in scope, as well as for effective and lean QMS structures and documents for Q&R processes at all levels of HT.

The role is responsible for establishing the quality management system and managing its deployment.

Ensures proper audit planning and schedule meet the requirements of internal policies and external regulations.

Establishes and executes a transition plan for all QMS in scope while maintaining compliance and effectiveness throughout the duration of the transition to the end-state QMS

Leads/participates in maintaining the documents until they are no longer applicable as part of the transition.

Ensures the addition and management of any local QMS documents in line with the evolution of the

Helps prepare the quarterly management review.

Responsible for drafting and updating Intra-company quality agreements.

Establishes, enforces, and oversees compliance for an effective Quality Management System (QMS) within the scope of activities, ensuring streamlined and efficient QMS structures and documentation across all levels of the Radiology Informatics Business Unit.

Manages the deployment of the QMS transition and ensures its effective implementation.

Plans and schedules audits, ensuring alignment with internal policies and external regulations.

Locally oversees the QMS components in scope, maintaining compliance and effectiveness throughout the transition duration.

Adds and manages local QMS documents in accordance with the evolving QMS.

Ensures training adherence and registration according to the QMS, generating training content for local QMS documents as needed.

Addresses issues of diverse scope, requiring analysis of various factors, including an understanding of business needs.

Advises the business on Quality Management System matters.

Leads and supports Document Control Specialists and Training Coordinators.

Serves as a Subject Matter Expert for Non-Product Software Validation (NPSS), Quality Management System (QMS), Document Control, Internal and External Audits, and Training.

Manages the Quality System Management Review process by collecting data, creating presentations, recording meeting minutes, and following up on action items.

Supports any other activities associated with QMS.

Experience:

8-12 years overall experience

At least 5+ years of experience in the medical device industry

Strong working knowledge of GMP’s and other FDA regulations

Experience validating application activities.

Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.

Experience with Software Medical Devices highly desire

Competency and Skills:

Solid Analytical skills - demonstrated ability to trouble-shoot complex process/system issues.

Strong IT skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications.

Proven analytical capabilities.

Excellent communication, organizational and project management skill.

Excellent communication skills in English is a must.

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.

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:
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
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.
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.

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