QA Specialist

We are looking for our future QA Engineer 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 regulators in every country.

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 Res Med’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 Res Med UK & South Africa (ZA) Quality Management Systems (QMS) are compliant and aligned with:

• Applicable regulatory standards / requirements
• Business requirements
• Other Res Med 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 Res Med 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 Res Med teams to ensure compliance with applicable regulation and Res Med 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 Res Med.
• 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.

• 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,…