
Chief Quality Excellence Officer
6 days ago
This role oversees the implementation and maintenance of quality management systems that ensure regulatory compliance across various frameworks.
Key responsibilities include designing, developing, and manufacturing products that meet customer requirements for quality. This involves creating and maintaining relationships with regulatory bodies to ensure timely registration in line with business needs.
Audit and ensure regulation compliance, quality best practices, process improvements, and supplier quality system development are core aspects of this position.
The role also entails providing broad technical support around QA systems and processes within the organization. It leads and implements significant quality projects across the business and creates and improves quality and business processes.
Global responsibility lies in aligning Quality Management Systems (QMS) across global quality systems. Maintenance and security of documentation systems and record-keeping are crucial components of this role.
Support is given to factory teams to achieve current KPIs for Quality, Delivery, and Cost. The role leads and supports new product introduction processes into manufacturing with active involvement in relevant deliverables and phase transitions in collaboration with QA counterparts.
Proactive improvement of quality systems is required to support manufacturing. Reviews are conducted across all areas of manufacturing and QA production support teams to ensure consistency and standardization in ResMed QMS across various manufacturing business units and sites.
Risks of non-compliance and related business risks must be mitigated. Quality/technical leadership is provided through mentoring/coaching.
Compliance to ResMed QMS is ensured; strong knowledge, application of, and compliance to FDA Quality System Regulations, GMP, and applicable ISO/regulatory standards are maintained.
Collaboration with various QA functions in ResMed (quality systems & audit, design, supplier, manufacturing, and customer quality) is essential.
Internal/external/supplier audits may be performed or supported. Partnerships are formed with stakeholders and other functions to understand business and quality requirements. Risk-based decision making is applied to achieve successful business and customer outcomes.
Required Skills and Qualifications:
- Strong understanding of quality management systems and regulatory frameworks
- Experience in implementing and maintaining quality management systems
- Ability to lead and implement quality projects
- Excellent communication and interpersonal skills
- Proven ability to work collaboratively across various functions
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