Quality Assurance Specialist

Resonant Clinical Solutions

Chorley

On-site

GBP 45,000 - 65,000

Full time

14 days+

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Benefits offered by this job

Healthcare coverage

Company bonus scheme

Pension scheme

Flexible working options

Wellbeing initiatives

Generous annual leave + birthday day

Job summary

Resonant Clinical Solutions is seeking a Quality Assurance Specialist to maintain and continuously improve the site’s Quality Management System (QMS), ensuring regulatory compliance and customer expectations. You will drive QA activities, manage CAPA and audit programmes, and lead process improvements across the business.

You will support supplier and customer quality initiatives, coordinate audits, monitor quality trends, and deliver training on quality processes.

Qualifications

Experience supporting or managing Quality Management Systems (QMS) within a regulated environment.
Knowledge of ISO 9001, ISO 13485, FDA QSR (21 CFR Part 820) or similar frameworks.
Experience conducting internal audits and supporting customer, supplier, or regulatory audits.
CAPA, complaint handling, non-conformance management, and root cause analysis.
Documentation control for SOPs and related quality documents.
Experience with quality software systems and electronic QMS.
Strong communication and stakeholder management skills.
Proficiency with Microsoft Office applications.
Ability to work independently while collaborating cross-functionally.

Responsibilities

Support management and continuous improvement of the site's QMS documentation.
Lead the control and revision of quality system documentation for compliance.
Manage CAPA programmes, investigation, effectiveness review and closure.
Plan and lead internal audits per ISO standards and regulations.
Support customer, supplier, and regulatory audits including responses and closures.
Coordinate supplier quality activities and supplier audits.
Support complaint investigations and trend monitoring for improvements.
Lead or support Lean, Six Sigma, Kaizen projects to strengthen quality systems.
Assist with validation activities and test protocol execution where required.
Drive quality software implementations and related tooling.

Skills

QMS experience

Regulatory standards

Internal audits

CAPA processes

Documentation control

Root cause analysis

Stakeholder management

MS Office

Independent worker

Cross-functional collaboration

Education

Bachelor's degree in Quality

Tools

ETQ Reliance

Job description

Role Mission

As a Quality Assurance Specialist, you will play a key role in maintaining and continuously improving the site's Quality Management System (QMS), ensuring compliance with regulatory requirements, industry standards, and customer expectations. You will support quality leadership by driving quality assurance activities, managing CAPA and audit programmes, supporting supplier and customer quality initiatives, and leading process improvement efforts that enhance operational excellence and compliance across the business.

Key Responsibilities

Support the management and continuous improvement of the site's Quality Management System (QMS), including the Quality Manual, SOPs, work instructions, forms, and associated documentation.
Lead the implementation, revision, and control of quality system documentation to ensure compliance and operational effectiveness.
Manage and support the CAPA programme, ensuring timely investigation, implementation, effectiveness review, and closure of corrective and preventive actions.
Plan, conduct, and lead internal audits in accordance with ISO 9001, ISO 13485, QSR, and other applicable standards.
Support customer, supplier, and regulatory audits, including audit preparation, responses, corrective actions, and closure activities.
Coordinate supplier quality activities, including supplier evaluations, performance reviews, and supplier audit programmes.
Support complaint investigations, ensuring timely review, escalation, resolution, and closure in line with quality requirements.
Monitor quality trends and performance metrics, identifying opportunities for continuous improvement and risk reduction.
Lead or support Lean, Six Sigma, Kaizen, and other continuous improvement initiatives to strengthen quality systems and operational performance.
Support validation activities, including the preparation and execution of protocols, testing, and documentation where required.
Drive the implementation and optimisation of quality management software systems, including ETQ Reliance modules and related tools.
Deliver training and guidance on quality processes, compliance requirements, and continuous improvement methodologies.
Evaluate emerging regulations, standards, and industry best practices, providing recommendations to support ongoing compliance and business readiness.
Collaborate cross-functionally with Operations, Supply Chain, Customer Service, and Leadership teams to promote a culture of quality and continuous improvement.

We’re looking for a proactive quality professional with experience working in regulated environments and a passion for continuous improvement. You will have strong knowledge of quality systems, auditing, and compliance, combined with the ability to influence stakeholders and drive meaningful change. This role is ideal for someone who enjoys balancing operational quality activities with strategic improvement initiatives.

Essential Skills And Experience

Experience supporting or managing Quality Management Systems (QMS) within a regulated environment.
Strong knowledge of quality standards and regulations, including ISO 9001, ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and/or similar regulatory frameworks.
Experience conducting internal audits and supporting customer, supplier, or regulatory audits.
Knowledge of CAPA processes, complaint handling, non-conformance management, and root cause analysis methodologies.
Strong documentation control experience, including SOP development, review, and implementation.
Excellent problem-solving and analytical skills with the ability to identify trends and drive improvements.
Experience working with quality software systems and electronic quality management systems (eQMS).
Strong communication and stakeholder management skills, with the ability to influence at all levels of the organisation.
Excellent organisational skills and the ability to manage multiple priorities and deadlines.
Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
Ability to work independently while collaborating effectively within cross-functional teams.

Desirable (but Not Essential)

Bachelor's degree in Quality, Life Sciences, Engineering, Business, or a related discipline.
Previous experience within medical devices, pharmaceuticals, biotechnology, clinical trials, healthcare, or other GxP-regulated industries.
Lead Auditor qualification or formal auditing certification.
Experience with ETQ Reliance or other electronic Quality Management Systems (eQMS).
Knowledge of EU MDR (745/2017) and IVDR (746/2017) regulations.
Lean Six Sigma Green Belt certification or experience applying Lean, Six Sigma, or Kaizen methodologies.
Experience supporting validation programmes and qualification activities.
Experience managing supplier quality programmes and supplier audits.
Project management experience, particularly within quality or compliance-focused initiatives.
Experience supporting global quality or regulatory compliance programmes.

What We Offer

At Resonant, we are more than a leading life sciences company – we’re a global team united by a shared purpose: the uncompromising pursuit of quality to help our customers move science forward. This role is based on-site, with a requirement to work from the office for a minimum of 2 days per week to support close collaboration and operational effectiveness. We are committed to helping you thrive, offering access to high-quality learning, development, and career progression opportunities so you can reach your full potential.

Competitive Reward Package Includes, Following Qualifying Periods