Quality Compliance Specialist - Maternity Cover

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

Manage, develop, improve and implement the organizational accreditation to ISO13485, Medical Device Single Audit Program(MDSAP) and other Regulatory requirements within the organization.

Reports to

Quality Manager

Location & Working pattern

Primary working locations: Keele office (IC4/5) & Trentham Warehouse (E2) facility occasionally. 

Standard working hours: Monday-Friday, 08.00–16.00 / 09.00–17.00

Duties & Responsibilities

• Lead and manage the organizational internal audit program.

• Oversee and mentor internal audit teams, ensuring adherence to deadlines and maintaining high standard of working.

• Lead and manage any third party audits acting as the SME.

• Coordinate and document any investigation and corrective actions relating to internal and external audit nonconformities.

• Develop, improve and write new Standard Operating Procedures and Work Instructions as required.

• Assist in the routine generation of trend analysis and quality data reports and metrics.

• Lead on assigned projects to improve quality/regulatory compliance

• The support and alignment of internal programs throughout the Biocomposites organizational as directed  

• The role may travelling and often nights away within the UK and on the odd occasion, overseas, to support the audit program.

• Identify and implement additional Quality Management System (QMS) requirements in line with Good Manufacturing Practice (GMP) requirements.

• Promote a culture of QMS and GMP compliance to preserve the quality of manufacturing , cleanroom environment and product.
• Support the organization in the implementation of new or revised QMS and /or GMP processes, procedures and equipment.

Essential requirements

• Level 6 degree or equivalent in scientific discipline (or 5+ years QMS / QA / auditing role)

• Worked in a quality / manufacturing environment within a regulated industry

• 5+ years auditing experience

• Working knowledge of QMS principles e.g. policies and procedures, regulatory requirements, internal and external audits, risk assessment, CAPA

• Excellent verbal, non-verbal and written communication skills.

• Accepts responsibility and able to prioritise tasks

• Car driver

• Valid Passport

Desirable requirements

• Qualified Lead Assessor

• Any QMS / QA related training

• Worked within healthcare (medical devices or pharmaceutical) manufacturing

• Working knowledge of QMS / GMP Procedures e.g. ISO 13485, ISO 14971, MDR (EU), QSR (US)

• Able to act on initiative and exhibit leadership qualities

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