QMS Specialist

Job Description

Job Title : QMS Specialist

Job Responsibilities:
u2022 Takes ownership of basic processes in the assigned area/ areas (Audits, Document Control, Training, CAPA) to ensure that QMS is efficient and meets the regulatory requirements.
u2022 Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
u2022 Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
u2022 Contributes to the development, implementation, and revision of QMS processes, including standard operating procedures (SOPs), work instructions, and quality manuals, ensuring their accuracy, clarity, and compliance with relevant standards.
u2022 Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
u2022 Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
u2022 Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
u2022 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.
u2022 Cultivates effective relationships with internal and external partners, providing influence over projects and peer groups by demonstrating a comprehensive understanding of the area of specialization.
u2022 Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
u2022 Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

Minimum required Education:
Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering

Minimum required Experience:
Minimum 8-10 years of experience with Bachelor's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive

Preferred Education:
Bachelor's or Master's in Engineering, Quality/ Regulatory/Compliance related fields

Mandatory Experience:

• Hands on experience with QMS processes (Document Control, Training, CAPA, change Management)

• Audit exposure(internal, external, FDA/Notified Body)

• Ability to work with R&D, Manufacturing and Regulatory affairs

Preferred Certification:
ISO 13485, FDA QSR( 21 CFR 820) knowledge, MDR awareness

Preferred Skills:
u2022 Regulatory Requirements
u2022 Quality Management Systems (QMS)
u2022 Project Management
u2022 Troubleshooting
u2022 KPI Monitoring and Reporting
u2022 Data Analysis & Interpretation
u2022 Process Improvements
u2022 Technical Writing
u2022 User Training & Support
u2022 Training Content Development
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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 companyu2019s facilities.
Field roles are most effectively done outside of the companyu2019s main facilities, generally at the customersu2019 or suppliersu2019 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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If youu2019re 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 .