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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. 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.
Job Responsibility:
Develop, implement, and monitor quality standards and procedures for operational 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
Responsibility for product Failure Mode and Effects Analysis (FMEA) creation and maintenance
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 implementation of corrective and preventive actions (CAPA), Non-conformances, Deviations and Complaints
Ensure products and processes comply with relevant industry regulations (e.g., ISO, FDA, etc.)
Assist with internal and external audits to ensure compliance with quality standards
Train team members and operators on quality standards, best practices, and inspection techniques
Provide support for troubleshooting quality issues and resolving customer complaints
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
Requirements:
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 industry-specific regulations ISO13485 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
Nice to have:
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)