QA Specialist in London

We are looking for our future QA - Engineer to join our Quality Assurance team in GB.

Let's talk about the role:

The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer's quality requirements. The management, maintenance, and optimisation of the structure and integrity of the Global Quality Management Systems (QMS) to ensure ResMed's products and operations comply with the regulatory requirements applicable to medical devices for the markets in which they are distributed.

Let's talk about key responsibilities:

• Support to ensure all aspects of the ResMed UK & South Africa (ZA) Quality Management Systems (QMS) are compliant and aligned with:

• Applicable regulatory standards/requirements
• Business requirements
• Other ResMed QMS entities when applicable

• Ensure the implementation of the actions, procedures, and processes necessary for the compliance of the Quality activities with the ResMed quality policy and the UK & ZA regulations in force, to achieve quality objectives.
• Proactively contribute to reviewing, analysing, and implementing opportunities for continual improvement of the QMS, quality documents and records in UK & ZA.
• Reporting to management any obstacles or potential hazards, that may impact on the effectiveness of the quality management system; and identify any need for improvement.
• Support Global and Regional ResMed teams as appropriate to ensure compliance to applicable regulation and ResMed standard procedures.

Let's talk about qualifications and experience:

• Required
• Bachelor's degree or Master in Science, Quality or Engineering
• Support the harmonization and standardization of processes and associated documentation across EMEA entities, where applicable.
• Work with corresponding Quality teams in other parts of ResMed to ensure Quality systems and processes are aligned.
• In addition to UK & ZA QMS responsibilities, provide support to other EMEA QS-managed QMS (e.g., Switzerland, EU QMS) as needed, and share expertise to advance team members' EMEA QMS projects.
• Promote a culture of quality through continuing education, consultation and contributing to management review; supporting the role of the Quality Management Representative.
• Conduct quality audits of suppliers and service providers by performing supplier audit programs that meet company and applicable external regulatory agency requirements.
• Minimum 5 years applied professional quality assurance experience ideally including the medical industry.
• Experience with CAPA and Audits.
• Strong planning and organization skills.
• Strong listening, verbal, and written communication skills.
• Ability to work remotely and effectively with remote teams, building and maintaining positive relationships while influencing change.
• Ability to collaborate at different functions such as business, distribution chain partners, Regulatory affairs team, ResMed Manufacturer team, operational, commercial and marketing teams.
• Knowledge of EU MDR 2017/745.
• Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
• Project management experience.
• Ability to think clearly and critically, assess information and evidence to make informed, timely decisions.
• Act as a role model for others within QA and the broader business.