QA Specialist

ResMed; East Hagbourne; On-site; GBP 60,000 - 80,000; Full time

Job summary

A global medical technology company is seeking a QA Engineer to join their Quality Assurance team in East Hagbourne, UK. The role focuses on ensuring compliance with regulatory standards and managing the Quality Management Systems. Ideal candidates have at least 5 years of experience in quality assurance within the medical field, strong organizational skills, and the ability to work with remote teams. The position offers work-from-home flexibility and participation in a bonus plan.

Benefits

Bonus plan

Referral bonus

Preferred shareholding programme

Internal career opportunities

Qualifications

• Minimum 5 years of 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.

Responsibilities

• Manage quality activities within the framework of the processes constituting the QMS in UK & ZA.
• Support Global and Regional teams to ensure compliance with regulations.
• Conduct quality audits of suppliers and service providers.

Skills

Strong planning and organisation skills

Strong listening, verbal and written communication skills

Proactive, able to provide initiative

Ability to work remotely and effectively with remote teams

Ability to collaborate at different functions

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 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 regulators in every country.

The Quality Assurance – Quality Systems function supports :

All aspects of the audit program to ensure regulatory 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; supporting and implementing significant quality projects across the business and improving quality and business processes.

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

Manage quality activities / actions within the framework of the processes constituting the QMS in UK & ZA:

• Ensure implementation of the actions, procedures and processes necessary for compliance with ResMed quality policy and UK/ZA regulations to achieve quality objectives.
• Proactively review, analyse and implement opportunities for continual improvement of the QMS, quality documents and records.
• Report to management any obstacles or potential hazards that may impact the effectiveness of the QMS and identify any need for improvement.
• Support Global and Regional ResMed teams to ensure compliance with applicable regulation and ResMed standard procedures.
• Contribute to establishing and maintaining metrics and feedback mechanisms to monitor continued effectiveness of UK & ZA QMS.
• Support the harmonization and standardization of processes and documentation across EMEA entities, working with corresponding Quality teams in other parts of ResMed.
• Provide support to other EMEA QMS (e.g., Switzerland, EU QMS) as needed, sharing expertise to advance team members’ EMEA QMS projects.
• Promote a culture of quality through continuing education, consultation and contributing to management review; support the role of the Quality Management Representative.
• Build positive working relationships with cross‑functional project teams to ensure Quality System Team activities are recognised 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, performing supplier audit programs that meet company and regulatory agency requirements.
• Support the response to audit findings and CAPAs in UK & ZA QMS.

Let’s talk about qualifications and experience :

• Required:

• Bachelor’s degree or Master in Science, Quality or Engineering.
• Minimum 5 years of 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 organisation skills.
• Strong listening, verbal and written communication skills.
• Proactive, able to provide initiative.
• Ability to work remotely and effectively with remote teams.
• Ability to collaborate at different functions.
• Acting as lead or experienced supporting auditor for internal and supplier audits.

• Preferred:

• 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. You also have access to a referral bonus and ResMed’s preferred shareholding programme, as well as internal career opportunities in an international fast‑paced and massively growing company.

Working from home flexibility is available.

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 thriving on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

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