PQMS Manager

Job Title

Job Description

Job Responsibilities:
Supervises day-to-day operations of the QMS team ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements.
Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control training and internal audits ensuring they are effective compliant and aligned with both regulatory requirements and business needs.
Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics identifying trends and developing action plans to address gaps enhance compliance and improve overall quality.
Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
Facilitates cross-functional collaboration to resolve quality-related issues working closely with other departments to ensure alignment and effective problem-solving.
Manages the documentation and resolution of non-conformance reports (NCRs) ensuring systematic tracking effective resolution and implementation of preventive measures to avoid recurrence.
Conducts risk assessments and manages risk mitigation activities identifying potential risks to product quality and QMS integrity and developing strategies to minimize their impact.
Drives continuous improvement initiatives within the QMS proposing and implementing enhancements to processes tools and systems to improve overall quality performance and operational efficiency.
Addresses difficult to moderately complex issues or problems requiring the evaluation of identifiable factors following established processes and operational policies in selecting methods and techniques for obtaining solutions.
Guides and mentors the QMS team actively contributing to employee selection performance management compensation management career development and overseeing operational processes.
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.

In addition oversee all the activities under NMPA management representative or site management representative role including but not limited to:

Manages compliance to NMPA regulations and other Regulatory Agencies as required guidelines and policies to all products and operations are consistent with those regulations.
Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.
Manages all inspections and questions relating to the operation of Goldway sites in coordination with all other applicable company groups
Manages product recall activities to include recall policies and procedures for the company. Additionally manage product compliant activities and all other post marketing surveillance activities.

- Manages all NMPA affairs relevant to quality.
Interact with all areas involved in the product development process customer services and sales and marketing and provide direction and consultation

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

Minimum required Experience:
Minimum 5 years of experience with Bachelors OR Minimum 5 years of experience with Masters in areas such as Quality Management Systems China management representative of medical devices Quality Audits or equivalent in highly regulated environments/industries such as MD Pharma Automotive.

Preferred Experience:
Management Representative for medical devices

Preferred Certification:
NMPA Management Representative certificate

Preferred Skills:
Regulatory Requirements
Quality Management Systems (QMS)
Project Management
Data Analysis & Interpretation
Process Improvements
Technical Writing
Budget Management
Agile Methodology
Training Content Development
Regulatory Compliance

How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
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.
If youre interested in this role and have many but not all of the experiences needed we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.