Job Title
QMS Specialist - MRI
Job Description
Job title:
QMS Specialist - MRI
Your role:
The QMS Specialist is responsible for overseeing QMS processes to ensure an efficient and compliant MR QMS, working under limited supervision. The role analyzes QMS processes and performance, preparing detailed reports and presenting findings to senior management. The role contributes to the development and revision of QMS processes, ensuring accuracy and compliance with relevant standards. The role participates in continuous improvement initiatives, enhancing processes and systems and applies specialized knowledge to solve complex challenges. The role cultivates effective relationships with internal and external partners, influencing projects and peer groups.
You're the right fit if: (4 x bullets max)
1. Experience:Minimum 10 years of experience with areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma.
2. Skills:
- Takes ownership of Quality processes to ensure that QMS is efficient and meets the regulatory requirements.
- Analyzes QMS metrics and performance indicators, preparing detailed reports that highlight trends, deviations, and areas for improvement, and presenting findings to senior management.
- Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
- 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.
- Conducts risk assessments activities, identifying potential risks to regulatory compliance, quality and QMS integrity, and developing robust mitigation strategies to minimize their impact.
- 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.
- 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.
- 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.
- Leads cross-functional problem-solving sessions to address significant QMS issues, utilizing structured methodologies like root cause analysis and driving the implementation of solutions.
- Coordinate, prepare for and participate in external and internal regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.
3. Education: Bachelor's / Master's Degree in Engineering
4. Anything else:
- Regulatory Requirements
- Audit Management
- Quality Management Systems (QMS)
- Project Management
- Troubleshooting
- KPI Monitoring and Reporting
- Data Analysis & Interpretation
- Process Improvements
- Technical Writing
- Agile Methodology
- User Training & Support
- Training Content Development
- Regulatory Compliance
- 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 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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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 .
