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Senior Quality Assurance Engineer - QARA

Job Posted: 5 hours ago

Salary: £ 48,000 - 52,000 / Annum
Job Type: Permanent
Location: Abingdon, Oxfordshire

Expire in: a month

Job Description

Senior Quality Assurance Engineer / Senior QARA Engineer / Senior Quality Engineer

Reporting to the QARA Manager, the Senior Quality Assurance Engineer supports the effective operation, maintenance, and continuous improvement of the Quality Management System. The role is responsible for ensuring organisational compliance with ISO 13485, FDA 21 CFR 820, and other applicable global quality and regulatory requirements. The Senior Quality Engineer ensures that all required company processes are properly established, implemented, and monitored for ongoing effectiveness, and provides technical quality leadership across the business to maintain high standards of product safety, quality, and regulatory conformity.

NOTE:- This position is only open to British/EU/ILR Applicants and offers no sponsorship.

MAIN TASKS

Quality and Regulatory:

Act as Deputy for the QARA Manager for all matters relating to Quality Assurance.

Maintain, develop, and improve the Quality Management System in alignment with ISO 13485, FDA 21 CFR 820, and other relevant global regulatory requirements.

Ensure compliance with national and international standards and legislation.

Maintain a suitable regulatory framework and associated processes and to update the quality and regulatory processes as necessary in line with new international or country specific legislation.

Support the QARA Manager in monitoring and ensuring compliance with applicable quality and regulatory standards.

Participate in regulatory inspections and provide technical quality support to demonstrate conformity.

Stay current with changes in quality and regulatory requirements and assist in implementing necessary updates.

Report to top management (KLT) on the performance of the quality management system, its KPI’s and any need for improvement.

Contribute to key QMS processes, including document control, change control, CAPA, NCR management, and risk management.

Review and approve controlled documents, engineering changes, and quality records to ensure compliance and accuracy.

Collaborate with R&D, engineering, production, and supply chain to ensure quality requirements are understood and met throughout the product lifecycle.

Support design verification, validation, and process validation activities, including drafting and reviewing protocols and reports.

Lead or support investigations into nonconformities and product issues, ensuring robust root cause analysis and effective corrective and preventive actions.

Promote a proactive quality culture across the organisation, encouraging continuous improvement and regulatory compliance.

Monitor and analyse key quality performance indicators.

Prepare regular quality reports, highlighting trends, risks, and opportunities for improvement to the QARA Manager.

Support supplier evaluation, qualification, and ongoing performance monitoring activities.

Contribute to incoming inspection processes, manufacturing quality controls, and cross-functional quality improvement initiatives

Support internal and external audits by preparing documentation, coordinating audit activities, and driving timely closure of actions.

To update the quality and regulatory processes as necessary in line with new international or country specific legislation.

Manage Supplier Quality processes including MRB / control of non-conforming process, working closely with Operations and Engineering teams.

Ensure that business is conducted in a professional manner according to the Organisation’s goals, vision, policies and procedures.

General Requirements

A strong understanding of Quality Management Systems within a regulated medical device environment, including ISO 13485, FDA 21 CFR 820, and related global regulatory standards.

Demonstrated experience supporting or managing core quality system processes such as CAPA, nonconformance management, change control, document control, and risk management.

Solid technical background with the ability to interpret engineering drawings, specifications, and validation/verification requirements.

Proven ability to investigate issues using structured problem-solving tools and conduct effective root cause analysis.

Excellent communication skills, with the ability to work collaboratively across departments and provide clear guidance on quality and compliance matters.

Strong organisational and analytical skills, with attention to detail and the ability to manage multiple priorities in a fast-paced environment.

Proficiency in preparing quality documentation, audit evidence, and quality reports.

Commitment to maintaining a high level of integrity, professionalism, and adherence to regulatory expectations.

Reporting to the QARA Manager, the Senior Quality Assurance Engineer supports the effective operation, maintenance, and continuous improvement of the Quality Management System. The role is responsible for ensuring organisational compliance with ISO 13485, FDA 21 CFR 820, and other applicable global quality and regulatory requirements. The Senior Quality Engineer ensures that all required company processes are properly established, implemented, and monitored for ongoing effectiveness, and provides technical quality leadership across the business to maintain high standards of product safety, quality, and regulatory conformity.

NOTE:- This position is only open to British/EU/ILR Applicants and offers no sponsorship.

MAIN TASKS

Quality and Regulatory:

Act as Deputy for the QARA Manager for all matters relating to Quality Assurance.

Maintain, develop, and improve the Quality Management System in alignment with ISO 13485, FDA 21 CFR 820, and other relevant global regulatory requirements.

Ensure compliance with national and international standards and legislation.

Maintain a suitable regulatory framework and associated processes and to update the quality and regulatory processes as necessary in line with new international or country specific legislation.

Support the QARA Manager in monitoring and ensuring compliance with applicable quality and regulatory standards.

Participate in regulatory inspections and provide technical quality support to demonstrate conformity.

Stay current with changes in quality and regulatory requirements and assist in implementing necessary updates.

Report to top management (KLT) on the performance of the quality management system, its KPI’s and any need for improvement.

Contribute to key QMS processes, including document control, change control, CAPA, NCR management, and risk management.

Review and approve controlled documents, engineering changes, and quality records to ensure compliance and accuracy.

Collaborate with R&D, engineering, production, and supply chain to ensure quality requirements are understood and met throughout the product lifecycle.

Support design verification, validation, and process validation activities, including drafting and reviewing protocols and reports.

Lead or support investigations into nonconformities and product issues, ensuring robust root cause analysis and effective corrective and preventive actions.

Promote a proactive quality culture across the organisation, encouraging continuous improvement and regulatory compliance.

Monitor and analyse key quality performance indicators.

Prepare regular quality reports, highlighting trends, risks, and opportunities for improvement to the QARA Manager.

Support supplier evaluation, qualification, and ongoing performance monitoring activities.

Contribute to incoming inspection processes, manufacturing quality controls, and cross-functional quality improvement initiatives

Support internal and external audits by preparing documentation, coordinating audit activities, and driving timely closure of actions.

To update the quality and regulatory processes as necessary in line with new international or country specific legislation.

Manage Supplier Quality processes including MRB / control of non-conforming process, working closely with Operations and Engineering teams.

Ensure that business is conducted in a professional manner according to the Organisation’s goals, vision, policies and procedures.

General Requirements

A strong understanding of Quality Management Systems within a regulated medical device environment, including ISO 13485, FDA 21 CFR 820, and related global regulatory standards.

Demonstrated experience supporting or managing core quality system processes such as CAPA, nonconformance management, change control, document control, and risk management.

Solid technical background with the ability to interpret engineering drawings, specifications, and validation/verification requirements.

Proven ability to investigate issues using structured problem-solving tools and conduct effective root cause analysis.

Excellent communication skills, with the ability to work collaboratively across departments and provide clear guidance on quality and compliance matters.

Strong organisational and analytical skills, with attention to detail and the ability to manage multiple priorities in a fast-paced environment.

Proficiency in preparing quality documentation, audit evidence, and quality reports.

Commitment to maintaining a high level of integrity, professionalism, and adherence to regulatory expectations

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