QMS Engineer

Job Description

Job Title : QMS Engineer

Job Responsibilities:
u2022 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.
u2022 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.
u2022 Contributes to continuous improvement initiatives by identifying opportunities for enhancing efficiency and compliance within existing QMS processes and providing support in implementing improvements.
u2022 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.
u2022 Ensures the proper maintenance, organization, and archiving of quality records in accordance with QMS procedures, regulatory requirements, and company policies to maintain audit readiness.
u2022 Collaborates with cross-functional teams and stakeholders to ensure effective communication and understanding of QMS processes, and provide basic guidance on compliance-related inquiries.
u2022 Participates in problem-solving sessions by providing data and insights related to quality processes, supporting the identification of root causes, and recommending potential corrective actions.
u2022 Works under general supervision and established processes, utilizing independent judgment to navigate and adhere to operational policies, ensuring compliance and optimal performance.
u2022 Engages in risk management activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and proposing mitigation strategies to minimize impact.
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 Develops professional expertise and applies comprehensive knowledge of company products and services to effectively address challenges and opportunities.

Minimum required Education:
Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

Minimum required Experience:
Minimum 5 -7 years of experience in Quality Management Systems, Quality Audits in highly regulated environments/industries such as Medtech , Pharma

Preferred Skills:
u2022 Regulatory Requirements
u2022 Quality Management Systems (QMS)
u2022 Troubleshooting
u2022 KPI Monitoring and Reporting
u2022 Data Analysis & Interpretation
u2022 Process Improvements
u2022 Agile Methodology
u2022 User Training & Support
u2022 Training Content Development
u2022 Business Acumen

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 .