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.
Key deliverables include creating and building relationships with medical device regulatory in every country.
The Quality Assurance - Quality Systems function supports:
1. 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.
2. 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:
3. 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
As well as other ResMed QMS entities when applicable.
4. Manage quality activities/actions within the framework of the processes constituting the Quality Management System in UK & ZA:
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.
5. Contribute toestablishing 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.
6. 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.
7. 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.
8. Promote a culture of quality through continuing education, consultation and contributing to management review; supporting the role of the Quality Management Representative.
9. 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.
10. Support global quality projects required for implementation in UK & ZA as well as in EMEA.
11. Conduct quality audits of suppliers and service providers by performing supplier audit programs that meet company and applicable external regulatory agency requirements.
12. Support the response to audit findings and CAPAs in UK & ZA QMS.
Let's talk about qualifications and exeperience:
Required
13. Bachelor’s degree or Master in Science, Quality or Engineering
14. Minimum 5 years applied professional quality assurance experience ideally including the medical industry
15. Experience with ISO 13485 Medical Standard and local regulations (UK law)
16. Experience with CAPA and Audits
17. Strong planning and organization skills
18. Strong listening, verbal, and written communication skills
19. Proactive, able to provide initiative
20. Ability to work remotely and effectively with remote teams, building and maintaining positive relationships while influencing change
21. Ability to collaborate at different functionssuch as business, distribution chain partners, Regulatory affairs team, ResMed Manufacturer team, operational, commercial and marketing teams
22. Acting as lead or experienced supporting auditor for internal and supplier audits, covering a range of relevant processes and supplier types
Preferred:
23. Knowledge of EU MDR 2017/745
24. Ability to identify linkages and dependencies between processes.
25. Experience in the maintenance of Management Systems including ongoing improvement of systems and processes.
26. Project management experience
27. Ability to think clearly and critically, assess information and evidence to make informed, timely decisions
28. Agility to adapt and respond quickly while being resilient to overcome obstacles
29. Act as a role model for others within QA and the broader business
Additional information :
30. At ResMed, all employees benefit from a bonus plan, the percentage of which depends on your position within the organisation.
31. Working from home flexibility
32. You also have access to a referral bonus and to ResMed's preferred shareholding programme
33. Internal career opportunity - joining an international fast-pace and massively growing company
OK, so what's next?
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 thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
#LI-EU
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 thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!