Engineer gezocht - Eastleigh, Hampshire, United Kingdom - ResMed Inc

Description

We are hiring a QA Engineer to join our Quality Assurance team in our Didcot office.

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:

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.

Support to ensure all aspects of the ResMed EMEA Quality Management Systems (QMS) are compliant and aligned with:
Applicable regulatory standards/requirements
Manage quality activities/actions within the framework of the processes constituting the Quality Management Systems in EMEA (as 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 European (or UK) 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 EMEAs

Reporting to management any obstacles or potential hazards, that may impact the effectiveness of the quality management system; Contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of QMS in EMEA to business and regulatory needs.

Promote a culture of quality through continuing education, consultation and contributing to management review.

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.

Work with corresponding Quality teams in other parts of ResMed to ensure Quality systems and processes are aligned.
Support global quality projects required for implementation 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 EMEA
Bachelor's degree or Master in Science, Quality or Engineering
Minimum 2 years applied professional quality assurance experience ideally including the medical industry
Experience with ISO 13485 Medical Standard and knowledge of EU MDR 2017/745 & local regulations
Strong planning and organization 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.

Act as a role model for others within QA and the broader business

At ResMed , all employees benefit from a bonus plan, the percentage of which depends on yourposition within the organisation .

You also have access to a referral bonus and to ResMed's preferred shareholding programme
Internal career opportunity - joining an international fast-pace and massively growing company
Where a culture driven by excellence helps you not only meet your goals, but also create new ones. Where a culture driven by excellence helps you not only meet your goals, but also create new ones.


At ResMed (NYSE:
RMD,


ASX:
RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives.

Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD and other chronic diseases.

Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice.

By enabling better care, we improve quality of life, reduce the impact of chronic disease and lower costs for consumers and healthcare systems in more than 140 countries.

ResMed Corporation is an equal opportunity employer and provides equal opportunity in employment for all qualified persons, without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

(ResMed is an E-Verify Employer.