PQMS Manager

Job Title

PQMS Manager

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:
• Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

• Minimum required Experience:
• Minimum 5 years of experience with Bachelor's OR Minimum 5 years of experience with Master's 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 company’s facilities.
• Field roles are most effectively done outside of the company’s 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 won't 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 you’re 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 .