Quality Engineer

Biocomposites; Keele; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading medical devices company in Keele is seeking a Quality Engineer to ensure high standards of quality for products and processes. You will focus on developing quality control measures and compliance with regulations while collaborating with various teams. Ideal candidates will have a Level 6 qualification and over 3 years of experience in quality assurance, alongside excellent problem-solving and communication skills. This role offers a competitive salary and comprehensive benefits.

Benefits

Competitive salary

Company pension

Employee discount

Free on-site parking

Qualifications

• 3+ years of experience in quality assurance or quality engineering.
• Familiarity with ISO 13485 and GMP.
• Experience with quality tools such as FMEA.

Responsibilities

• Develop and monitor quality standards and procedures.
• Ensure compliance with industry regulations.
• Train team members on quality standards and practices.

Skills

Problem-solving

Statistical analysis

Communication skills

Organizational skills

Education

Level 6 in Quality Engineering or related field

Tools

Quality management systems (QMS)

Lean methodologies

Six Sigma

Job description

Overview

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 leads 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 used in over one million procedures per annum and sold in more than 100 countries around the world.

Summary

As a Quality Engineer, you will be responsible for ensuring the highest standards of quality for products and processes. Your role will focus on identifying areas for improvement, developing quality control measures, and ensuring compliance with industry regulations and company policies. You will work closely with cross-functional teams to guarantee that products meet the specifications and standards expected by customers.

Responsibilities

• Quality Assurance & Control
  • Develop, implement, and monitor quality standards and procedures for production processes.
  • Perform inspections, tests, and audits on materials, components, and finished products.
  • Analyze data from inspections and tests to identify trends and areas for improvement.
• Process Improvement
  • Identify opportunities for process optimization, waste reduction, and cost savings while maintaining quality standards.
  • Collaborate with engineering, manufacturing, and other departments to conduct root cause analysis and support the implementation of corrective and preventive actions (CAPA).
• Compliance & Documentation
  • Ensure products and processes comply with relevant industry regulations (e.g., ISO, FDA).
  • Create and maintain quality documentation such as inspection reports, certifications, and validation protocols.
  • Assist with internal and external audits to ensure compliance with quality standards.
• Training & Support
  • Train team members and operators on quality standards, best practices, and inspection techniques.
  • Provide support for troubleshooting quality issues and resolving customer complaints.
• Continuous Monitoring
  • Monitor key quality metrics to assess performance and suggest improvements.
  • Work with suppliers and vendors to ensure that materials and components meet required quality specifications.

Experience & Qualifications

• Level 6 in Quality Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
• 3+ years of experience in a quality assurance or quality engineering role.
• Familiarity with ISO 13485 and GMP.
• Strong problem-solving and troubleshooting skills.
• Excellent communication and project management skills.
• Ability to work in cross-functional teams and manage multiple projects simultaneously.
• Proficient in statistical analysis, root cause analysis, and corrective action processes.
• Attention to detail and strong organizational skills.
• Experience with quality management systems (QMS), Lean, Six Sigma, or other process improvement methodologies is a plus.
• Familiarity with quality tools such as control charts, fishbone diagrams, and failure mode effects analysis (FMEA).

What we offer

• Competitive salary and benefits.
• We grow talent: opportunities to thrive and grow.
• One Biocomposites – team spirit and engagement. We strive for engaged, inclusive global teams.

Who we look for

• People who are passionate about what we do.
• Open-minded to evolving the way we work.
• Collaborative and capable of transforming outcomes and changing lives.

Benefits

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