QA - Engineer

Resmed; United Kingdom; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading medical device company is looking for a QA - Engineer to join their Quality Assurance team in the UK. The role focuses on ensuring compliance with regulatory requirements and supporting quality management systems. Candidates should have a Bachelor’s degree or higher in a relevant field, with at least 5 years of experience in quality assurance, preferably in the medical industry. Excellent communication skills and project management experience are essential. This position allows for remote work.

Qualifications

• Minimum 5 years applied professional quality assurance experience ideally including the medical industry.
• Experience with CAPA and Audits.
• Knowledge of EU MDR 2017/745.

Responsibilities

• Ensure compliance of Quality Management Systems (QMS) with regulatory standards.
• Contribute to continual improvement of QMS and related documents.
• Support global quality projects in UK & ZA.

Skills

Quality assurance experience

Strong planning and organization skills

Strong listening, verbal, and written communication skills

Ability to work remotely

Project management experience

Education

Bachelor’s degree or Master in Science, Quality or Engineering

Job description

**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 + As well as other ResMed QMS entities when applicable.* 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.* 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.* Support the response to audit findings and CAPAs in UK & ZA QMS.**Let's talk about qualifications and exeperience:***Required** Bachelor’s degree or Master in Science, Quality or EngineeringSupport 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 industryExperience with CAPA and Audits Strong planning and organization skillsStrong listening, verbal, and written communication skillsAbility to work remotely and effectively with remote teams, building and maintaining positive relationships while influencing changeAbility to collaborate at different functions such as business, distribution chain partners, Regulatory affairs team, ResMed Manufacturer team, operational, commercial and marketing teamsKnowledge 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 decisionsAct as a role model for others within QA and the broader business