Philips

1 week ago

PQMS Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Supervise day-to-day operations of the QMS team and ensure quality processes are deployed, maintained, and continuously improved to meet regulatory and business needs. Monitor QMS performance metrics, manage non-conformances and risk assessments, and prepare for external audits and inspections with complete documentation and responses. Oversee NMPA management representative/site management representative activities, including compliance, product review and approvals, recall, and post-marketing surveillance, while guiding and mentoring the team.

Location: Shenzhen

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Supervise day-to-day QMS team operations, ensuring quality processes are executed efficiently and in compliance with company policies and requirements.
•Manage deployment and maintenance of QMS processes, including document control, training, and internal audits, aligned with regulatory requirements and business needs.
•Monitor and report QMS effectiveness using performance metrics, identify trends and gaps, and develop action plans to enhance compliance and overall quality.
•Prepare for and support external audits and inspections by ensuring documentation availability and providing responses to audit findings; manage non-conformance reports (NCRs) and preventive measures.
•Oversee NMPA management representative/site management representative activities, including NMPA regulatory compliance, finished product review/approval, Goldway site inspections, product recall, and post-marketing surveillance.

Key Requirements

•Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
•Minimum 5 years of experience with quality management systems (QMS), China management representative of medical devices, quality audits, or equivalent in highly regulated environments (e.g., medical devices, pharma, automotive).
•Experience as a management representative for medical devices.
•NMPA Management Representative certificate (preferred).
•Knowledge of regulatory requirements, regulatory compliance, and quality management systems; strong technical writing skills.

Experience:5+ yearsMedical devicesPharmaAutomotiveHighly regulated environmentsQuality management systems (QMS)

Education:Bachelor's in Mechanical Engineering, Industrial Engineering, Science

Skills:MentoringCross-functional collaborationProblem-solvingContinuous improvementTraining

Certifications:NMPA Management Representative certificate

Company Brief

Philips

Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn

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Philips

1 week ago

PQMS Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 11 hours agoStatus: Live

Job Summary

Location: Shenzhen

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Manager level

Key Responsibilities

•Supervise day-to-day QMS team operations, ensuring quality processes are executed efficiently and in compliance with company policies and requirements.
•Manage deployment and maintenance of QMS processes, including document control, training, and internal audits, aligned with regulatory requirements and business needs.
•Monitor and report QMS effectiveness using performance metrics, identify trends and gaps, and develop action plans to enhance compliance and overall quality.
•Prepare for and support external audits and inspections by ensuring documentation availability and providing responses to audit findings; manage non-conformance reports (NCRs) and preventive measures.
•Oversee NMPA management representative/site management representative activities, including NMPA regulatory compliance, finished product review/approval, Goldway site inspections, product recall, and post-marketing surveillance.

Key Requirements

•Bachelor's or Master's degree in Mechanical Engineering, Industrial Engineering, Science, or equivalent.
•Minimum 5 years of experience with quality management systems (QMS), China management representative of medical devices, quality audits, or equivalent in highly regulated environments (e.g., medical devices, pharma, automotive).
•Experience as a management representative for medical devices.
•NMPA Management Representative certificate (preferred).
•Knowledge of regulatory requirements, regulatory compliance, and quality management systems; strong technical writing skills.

Experience:5+ yearsMedical devicesPharmaAutomotiveHighly regulated environmentsQuality management systems (QMS)

Education:Bachelor's in Mechanical Engineering, Industrial Engineering, Science

Skills:MentoringCross-functional collaborationProblem-solvingContinuous improvementTraining

Certifications:NMPA Management Representative certificate

Company Brief

Philips

Industry: HealthTech

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Amsterdam, Netherlands

Founded: 1891

Glassdoor: 3.8

Website LinkedIn