QA Specialist in Didcot

We are looking for our future QA Specialist to join our Quality Assurance team in GB. The primary role of the 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.

Key deliverables include creating and building relationships with medical device regulatory in every country. The Quality Assurance - Quality Systems function supports:

• All aspects of the audit program to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems.
• Providing broad business technical support around QA systems and processes to the organization.
• Supports and implements significant quality projects across the business and also creates and improves quality and business processes.

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.

Key responsibilities include:

• 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 and business requirements.
• Manage quality activities/actions within the framework of the processes constituting the Quality Management System in UK & ZA.
• 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.
• Contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of UK & ZA QMS to business and regulatory needs.
• Ensure effective communication with relevant parties.
• 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.
• 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.
• Build positive working relationships with cross-functional project teams to ensure Quality System Team activities are recognized as an integral part of business success and growth.
• Support global quality projects required for implementation in UK & ZA as well as in EMEA.
• Conduct quality audits of suppliers and service providers by performing supplier audit programs that meet company and applicable external regulatory agency requirements.
• Support the response to audit findings and CAPAs in UK & ZA QMS.

Qualifications and experience required:

• Bachelor’s degree or Master in Science, Quality or Engineering.
• Minimum 5 years applied professional quality assurance experience ideally including the medical industry.
• Experience with ISO 13485 Medical Standard and local regulations (UK law).
• Experience with CAPA and Audits.
• Strong planning and organization skills.
• Strong listening, verbal, and written communication skills.
• Proactive, able to provide initiative.
• 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.
• Acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types.

Preferred qualifications:

• Knowledge of EU MDR 2017/745.
• Ability to identify linkages and dependencies between processes.
• 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.
• Agility to adapt and respond quickly while being resilient to overcome obstacles.
• Act as a role model for others within QA and the broader business.

Additional information:

• At ResMed, all employees benefit from a bonus plan, the percentage of which depends on your position within the organisation.
• Working from home flexibility.
• You also have access to a referral bonus and to ResMed's preferred shareholding programme.
• Internal career opportunity - joining an international fast-paced and massively growing company.

If this sounds like the workplace for you, apply now!