
Quality Management Specialist
2 weeks ago
Role Overview
Senior Associate/Principal AssociateThis role supports the development and implementation of quality systems to achieve business objectives.
- The key responsibility is to execute quality system deliverables, ensuring compliance with regulatory requirements.
This involves oversight of quality management activities, including collection, monitoring, evaluation, and communication of safety information.
The role will also provide Business Quality Assurance support to Tech projects, ensuring quality is integrated into automation and innovation.
Main Responsibilities:- Quality System Implementation:
- Develop and manage quality procedures and related documents, including review and approval of content as assigned.
- Recommend new quality documents or changes to existing ones where applicable.
- Advise on appropriate training for implementation and documentation.
- Provide consultation on the interpretation and application of external requirements, standards, and procedures.
- Responsible for deviations, change controls, Notification to Management, and completion of events.
- Consult on root cause analysis and corrective actions, including review and approval as necessary.
- Provide input into risk assessments, audit planning, and quality plans based on identified risks and gaps.
- Complete self-inspections and drive improvements that are meaningful and actionable.
- Ensure local implementation of quality systems as necessary.
- Quality Oversight:
- Monitor compliance to quality documents and anticipate gaps, proposing solutions.
- Communicate and escalate to management as necessary.
- Ensure implementation of Quality Plans as necessary.
- Monitor progress of actions and provide updates to quality and business owners.
- Simplify and improve processes, coordinate quality improvement initiatives, and review metrics and trends to enhance compliance.
- Audits and Inspections:
- Support audits and inspections, coordinating preparation, responses, and follow-up.
- Ensure inspection readiness, organization, and availability of documents.
- Lead and/or support readiness activities in collaboration with business partners.
- Partnership with other areas:
- Function as a point of consultation for business areas on quality-related questions.
- Partner with business areas to strengthen quality controls and share key learnings.
- Collaborate with other quality groups, establish relationships, and participate in team meetings.
- Support issue resolution, escalation, and utilize a risk-based approach in guiding business areas.
- Serve as an IT Business Quality Assurance representative for assigned IT systems.
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