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Quality Compliance Specialist

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360 Resourcing Solutions

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Location:
United Kingdom , Keele

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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

Job Responsibility:

  • 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

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

Nice to have:

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

Additional Information:

Job Posted:
April 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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