QMS Specialist
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
QMS SpecialistJob Description
Job title:
QMS Specialist
Your role:
- 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 proper maintenance organization and achieving 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 identification 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.
- Participate 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
Youre the right fit if: (4 x bullets max)
1. Experience- 8 years of industry experience prefer in Medtech QMS ISO 13485
2. Skills-
- 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.
3. Education- Any Engineering
4. Anything else-
Regulatory Requirements
Quality Management Systems (QMS)
Troubleshooting
KPI Monitoring and Reporting
Data Analysis & Interpretation
Process Improvements
Agile Methodology
User Training & Support
Training Content Development
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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre 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.
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
