Senior Quality Manager

1 week ago

Perth, Western Australia Bebeequality Full time

Quality Assurance Role
The primary function of Quality Assurance is to establish systems ensuring business compliance and regulatory frameworks. This involves supporting the design, development, and manufacture of products that meet customer quality requirements.
Key deliverables include creating relationships with medical device regulatory bodies in every country and ensuring timely registration to meet business needs. Also responsible for auditing to ensure regulation compliance, quality best practice, process improvements, and supplier quality system development.
This role provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and creates and improves quality and business processes.
Global responsibility for Quality Management System (QMS) alignment across global quality systems. Maintenance and security of documentation systems and record-keeping.
Support the Factory Focus teams to achieve current KPI of Quality, Delivery, and Cost. Lead and support new product introduction processes into manufacturing with active involvement in appropriate deliverables and phase transitions in collaboration with QA counterpart.
Proactively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support teams to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites.
Ensure risk of non-compliance and related business risks are mitigated. Provide quality/technical leadership through mentoring/coaching.
Ensure compliance to ResMed QMS; strong knowledge, application of, and compliance to FDA Quality System Regulations, GMP, and applicable ISO/regulatory standards.
Ability to work collaboratively across various QA functions in ResMed (quality systems & audit, design, supplier, manufacturing, and customer quality).
Perform or support internal/external/supplier audits. Partner with stakeholders and other functions to understand business & quality requirements and apply appropriate risk-based decision making to achieve successful business and customer outcomes.
Required Skills and Qualifications:
Bachelor's degree in Engineering or Science with 5 years' experience in a regulated volume manufacturing industry.
Experience in Quality Systems/Mfg. quality, risk management, requirements management, and process validation.
Self-starter, with ability to work with minimal supervision and sense of urgency.
Good planning and organizational skills; ability to take own initiative and ownership.
Strong interpersonal, communication, and negotiation skills with ability to interact positively with senior management and manage stakeholders.
Ability to work effectively with global teams, maintaining good relationships while influencing change.
Benefits:
Joining us is more than saying 'yes' to making the world a healthier place. It's discovering a career that's challenging, supportive, and inspiring. Where a culture driven by excellence helps you not only meet your goals but also create new ones.
We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thriving on the innovative ideas this generates.

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