QMS Specialist DXR

The QMS & CAPA Specialist supports the establishment of a compliant and effective Quality Management System (QMS) by developing and revising QMS process documents. This role involves tracking and monitoring CAPA activities, utilizing tools like Root Cause Analysis and FMEA, and contributing to continuous improvement. The specialist collects and reports QMS performance data, participates in internal audits, and ensures proper maintenance of quality records. Collaboration with cross-functional teams and engagement in risk management are also key responsibilities.

Must Have

• Bachelor’s degree in engineering (Electrical, Mechanical, Industrial) or Science equivalent
• 8+ years of experience in Quality Management Systems within manufacturing, medical devices, electronics, or similar regulated industries
• Hands-on experience with CAPA management and tools (RCA, 5 Whys, Fishbone Diagram, FMEA) along with KPI Monitoring & reporting
• Strong understanding of ISO 9001, ISO 13485, or equivalent QMS standards
• Proficiency in QMS software and document control systems
• Familiarity with risk management methodologies and audit processes
• Excellent analytical and problem-solving skills
• Strong communication and collaboration abilities for cross-functional work
• Analytical & Detail-oriented with a proactive approach to compliance and continuous improvement

Good to Have

• Certified Quality Auditor (CQA)
• Six Sigma Green Belt, or equivalent

Job Title

QMS Specialist DXR

Job Description

Job title: QMS and CAPA Specialist

The QMS & CAPA Specialist is responsible for supporting the establishment of a compliant and effective Quality Management System (QMS) for the activities in scope. The role participates in developing and revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy and currency. The role works under general supervision, and collaborates with cross-functional teams to resolve quality issues through root cause analysis and corrective actions. The role collects and reports data on QMS performance metrics and tracks non conformance reports, contributing to continuous improvement activities.

Your Role:

Supports CAPA (Corrective and Preventive Action) management by tracking, documenting, and monitoring CAPA activities, ensuring timely closure, effectiveness verification, and compliance with regulatory and company standards.

Utilizes CAPA tools such as Root Cause Analysis (RCA), 5 Whys, Fishbone Diagram (Ishikawa), Failure Mode and Effects Analysis (FMEA), and Risk Assessment to identify issues and implement robust corrective actions.

Participates in the effective deployment and continuous improvement of QMS processes in the assigned area/ areas such as document control, training, and audits, by providing technical expertise and ensuring compliance with regulatory standards.

Collects, compiles, and reports data on QMS performance metrics, such as non-conformances, critical findings, and training completion rates, to support management in decision-making.

Contributes to continuous improvement initiatives by identifying opportunities for enhancing efficiency and compliance within existing QMS processes and providing support in implementing improvements.

Participates in the planning and organization of internal audits by preparing necessary documentation, assisting audit teams during audits, and ensuring follow-up actions are completed.

Ensures the proper maintenance, organization, and archiving of quality records in accordance with QMS procedures, regulatory requirements, and company policies to maintain audit readiness.

Collaborates with cross-functional teams and stakeholders to ensure effective communication and understanding of QMS processes, and provide basic guidance on compliance-related inquiries.

Participates in problem-solving sessions by providing data and insights related to quality processes, supporting the identication of root causes, and recommending potential corrective actions.

Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational policies, ensuring compliance and optimal performance.

Engages in risk management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and proposing mitigation strategies to minimize impact.

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.

Develops professional expertise and applies comprehensive knowledge of company products and services to effectively address challenges and opportunities.

You're the right fit if you have:

Education: Bachelor’s degree in engineering in Electrical ,Mechanical, Industrial or Science equivalent.

Experience:

• 8+ years of experience in Quality Management Systems within manufacturing, medical devices, electronics, or similar regulated industries.
• Hands-on experience with CAPA management and tools (RCA, 5 Whys, Fishbone Diagram, FMEA) along with KPI Monitoring & reporting

Technical Skills:

• Strong understanding of ISO 9001, ISO 13485, or equivalent QMS standards.
• Proficiency in QMS software and document control systems.
• Familiarity with risk management methodologies and audit processes.

Soft Skills:

• Excellent analytical and problem-solving skills.
• Strong communication and collaboration abilities for cross-functional work.
• Analytical & Detail-oriented with a proactive approach to compliance and continuous improvement.

Certifications (Preferred):

• Certified Quality Auditor (CQA), Six Sigma Green Belt, or equivalent.

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.

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• Discover our rich and exciting history

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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

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