
Change Management Process Improvement Specialist
7 days ago
We are seeking a highly skilled Quality Management System (QMS) Change Management Specialist to drive process improvements and ensure compliance with industry standards.
The successful candidate will be responsible for reviewing, updating, and creating QMS Change Management processes to enhance organizational efficiency and effectiveness.
This role involves collaborating with stakeholders across Technical Operations, Development Operations, Services Validation, Support, and Quality teams to define and gather requirements for QMS Change Management processes.
Key responsibilities include:
- Requirements Definition and Gathering: Collaborate with stakeholders to define and gather detailed requirements for QMS Change Management processes. Document and prioritize requirements to ensure alignment with organizational objectives and compliance standards.
- Process Updates and Creation: Analyze existing QMS Change Management processes to identify areas for improvement and ensure they meet current regulatory and compliance requirements. Design, develop, and implement updated and new QMS Change Management processes.
- Stakeholder Collaboration: Work closely with cross-functional teams to ensure seamless integration and alignment of new and updated processes. Facilitate effective communication and collaboration between stakeholders to ensure successful process adoption and implementation.
- Compliance and Quality Assurance: Ensure that all QMS Change Management processes comply with relevant industry standards, regulations, and best practices. Conduct regular audits and reviews to ensure ongoing compliance and effectiveness of QMS Change Management processes.
Strong knowledge of industry standards and regulations related to Quality Management Systems (e.g., ISO 9001, ISO 13485, FDA regulations) is essential for this role.
Proven experience in process analysis, design, and implementation, as well as hands-on experience with AWS Cloud Services, is also required.
Candidates should have excellent communication, collaboration, and stakeholder management skills, as well as strong analytical and problem-solving abilities.
Proficiency in using QMS software and tools is a must.
BenefitsThis is an exciting opportunity to join our team and contribute to driving business growth through process improvements and compliance enhancements.
As a Quality Management System (QMS) Change Management Specialist, you will play a key role in shaping the future of our organization and ensuring that we continue to deliver high-quality products and services.
OthersThe ideal candidate will have at least 5 years of experience in Quality Management Systems and Change Management, preferably within the digital science automation or related industry.
Certification in Quality Management (e.g., Six Sigma, Lean, ASQ) is a plus.
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