Quality Compliance Lead

Biocomposites; Keele; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Company pension

Employee discount

Free parking

On-site parking

Company events

Job summary

Biocomposites in Keele is seeking a Quality Compliance Lead to develop and sustain the QMS/eQMS framework, ensuring regulatory alignment across ISO13485, MDSAP, GMP and FDA standards. You will coordinate audits, drive improvements, and lead a cross-functional team.

The role reports to the Quality Manager and requires travel both nationally and internationally, with standard office hours at Keele. A strong leadership background and lead auditor certification are essential.

Qualifications

• Experience leading QMS/eQMS in the medical devices sector.
• Extensive knowledge of ISO13485 and regulatory inspections.
• Ability to plan and lead internal and external audits.
• Experience with ERP and EDMS systems.
• Strong communication, leadership and deadline discipline.

Responsibilities

• Lead and maintain QMS/eQMS compliance across the organization.
• Ensure adherence to ISO13485, MDSAP, GMP and FDA standards.
• Plan, coordinate and lead internal and supplier audits.
• Monitor quality performance via KPIs and report trends.
• Review quality documentation and approve change controls.
• Drive quality improvements and deliver training.
• Manage a team and support regulatory inspections.
• Travel nationally and internationally as required.

Skills

Quality management

Lead auditor

Regulatory compliance

Communication skills

People management

Initiative

Deadline management

Attention to detail

Driving licence

Education

Level 6 in science regulated industry or equivalent

Lead auditor certification

Tools

ERP

EDMS (Electronic Document Management System)

Job description

Job Description

Biocomposites is an international medical devices company that engineers, manufactures, and markets world leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world.

Job Summary

The Quality Compliance Lead is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System (QMS) and Electronic Quality Management System (eQMS). This role ensures compliance with applicable regulatory requirements, industry standards, and internal quality policies. Working closely with cross-functional teams, the Quality Compliance Lead promotes a culture of quality and drives continuous improvement to strengthen quality performance and reduce compliance risk.

Reports to

Quality Manager

Location & Working pattern

Keele Office. Standard working hours (Mon – Fri, 8am-4pm or 9am-5pm, 35hpw)

Duties & Responsibilities

• Lead and maintain compliance with the organization's Quality Management System (QMS) and Electronic Quality Management System (eQMS).
• Ensure adherence to applicable regulatory requirements, customer standards, and industry regulations (ISO 13485, MDSAP, GMP, FDA, or other relevant standards).
• Plan, coordinate, and lead internal quality audits and support external audits, customer audits, and regulatory inspections.
• Plan, coordinate, and lead any supplier audits.
• Monitor compliance against quality procedures, policies, and regulatory requirements, identifying areas for improvement.
• Monitor quality system performance through key performance indicators (KPIs) and report trends to management.
• Review and approve quality documentation, ensuring adherence to applicable regulatory requirements, customer standards, and industry regulations (ISO 13485, MDSAP, GMP, FDA, or other relevant standards).
• Drive continuous improvement initiatives using quality improvement methodologies.
• Deliver quality training and promote awareness of quality system requirements throughout the organization.
• Maintain quality records and ensure document retention requirements are met.
• Stay informed of changes to relevant regulations and quality standards.
• Management and Development of a team
• Role will require some travel nationally and internationally.

Essential requirements

• Level 6 within a science regulated industry or relevant experience
• Minimum 6 years quality management experience within Pharmaceutica/Medical Devices
• Knowledge of Quality Management Systems ISO13485
• Lead auditor certification
• Experience with regulatory inspections and customer audits
• Familiarity with ERP and electronic document management systems
• Excellent communication skills
• People management skills
• Ability to take initiative within controlled working environment
• Ability to meet deadlines
• Attention to detail

Desirable requirements

• Level 5 in Leadership Management
• Member of a chartered institute
• Demonstrate positive and enthusiastic attitude
• Full, clean driving licence

What do we offer?

Competitive salary and benefits!With us, you will receive a competitive salary package and benefits.

We grow talent.At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement.Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free parking
• On-site parking