Senior QMS Manager

Private Advertiser; Santo Niño 1st; On-site; PHP 1,200,000 - 2,000,000; Full time

Job summary

Private Advertiser seeks an experienced Senior Manager, QMS to lead, maintain, and continually improve the site Quality Management System ensuring compliance with FDA QMSR, ISO 13485, MDSAP, and Singapore HSA requirements.

You will collaborate with Operations, Regulatory Affairs, Supplier Quality, Product Quality, and Corporate Quality to strengthen regulatory compliance, audit readiness, and QMS effectiveness across the site.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Quality Management, or related discipline.
• 10 to 15 years of QMS experience within a regulated manufacturing environment.
• At least 5 years in a managerial or senior quality leadership role.
• Strong knowledge of FDA QMSR, ISO 13485:2016, MDSAP, ISO 14971, CAPA, and inspection readiness.
• Proven experience as a QMS Lead, Management Representative, Lead Internal Auditor, or audit host.
• ISO 13485 Lead Auditor certification preferred; ASQ CQE, CQA, RAC or equivalent an advantage.

Responsibilities

• Own and maintain the site Quality Management System.
• Serve as the Site QMS Lead and subject matter expert.
• Lead Management Reviews, internal audits, CAPA, and quality governance activities.
• Maintain site-wide regulatory inspection and audit readiness.
• Host FDA, ISO 13485, MDSAP, certification body, and customer audits.
• Monitor regulatory changes and implement required compliance actions.
• Drive QMS metrics, quality objectives, and continual improvement initiatives.
• Partner with cross-functional teams to promote a strong quality culture.
• Interface with customers, auditors, regulatory agencies, and corporate stakeholders.

Skills

Leadership

Communication

Stakeholder management

Problem-solving

Auditing

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

We are seeking an experienced Senior Manager, QMS to lead, maintain, and continually improve the site Quality Management System. This role ensures compliance with FDA QMSR, ISO 13485, MDSAP, Singapore HSA requirements, corporate standards, and customer requirements.

You will work closely with Operations, Engineering, Regulatory Affairs, Supplier Quality, Product Quality, Program Management, and Corporate Quality to strengthen regulatory compliance, audit readiness, and overall QMS effectiveness.

Key Responsibilities

• Own and maintain the site Quality Management System.

• Serve as the Site QMS Lead and subject matter expert.

• Lead Management Reviews, internal audits, CAPA, and quality governance activities.

• Maintain site-wide regulatory inspection and audit readiness.

• Host FDA, ISO 13485, MDSAP, certification body, and customer audits.

• Monitor regulatory changes and implement required compliance actions.

• Drive QMS metrics, quality objectives, and continual improvement initiatives.

• Partner with cross-functional teams to promote a strong quality culture.

• Interface with customers, auditors, regulatory agencies, and corporate stakeholders.

Requirements

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Quality Management, or a related discipline.

• 10 to 15 years of QMS experience within a regulated manufacturing environment.

• At least 5 years in a managerial or senior quality leadership role.

• Medical device manufacturing experience is strongly preferred.

• Strong knowledge of FDA QMSR, ISO 13485:2016, MDSAP, ISO 14971, CAPA, and inspection readiness.

• Proven experience as a QMS Lead, Management Representative, Lead Internal Auditor, or external audit host.

• Strong leadership, communication, stakeholder management, and problem-solving skills.

• ISO 13485 Lead Auditor certification is preferred. ASQ CQE, CQA, RAC, or equivalent certification is an advantage.

What We Offer

• Opportunity to lead the QMS for a medical device manufacturing site.

• Exposure to regional and global quality stakeholders.

• A key leadership role in driving compliance, audit readiness, and quality excellence.