Generous annual bonus; pension schemes; save as yo...
Hybrid
5+ years quality assurance experience
Gmp gdp iso 9001 iso 13485 compliance
Us fda 21 cfr part 820 knowledge
Smith+Nephew is seeking a Quality Control Release Specialist 2 to ensure compliance with regulatory requirements and internal quality systems for manufactured products. The role involves leading QC release processes, training personnel, and supporting continuous improvement initiatives within the quality compliance framework
Job Summary
The role ensures Smith+Nephew complies with key regulatory requirements and procedures for the release of manufactured medical devices.
Candidates must possess advanced working knowledge of company products, processes, and personnel specifically associated to the QC release process.
The position offers a hybrid working model, generous annual bonus, pension schemes, and comprehensive health and wellbeing benefits.
Matching Summary
Match Score: 85
Smith+Nephew is seeking a Quality Control Release Specialist 2 to ensure compliance with regulatory requirements and internal quality systems for manufactured products. The role involves leading QC release processes, training personnel, and supporting continuous improvement initiatives within the quality compliance framework.
Salary
Generous annual bonus; Pension schemes; Save As You Earn share options
Skills & Requirements
Must-have
5+ years Quality Assurance experience
GMP GDP ISO 9001 ISO 13485 compliance
US FDA 21 CFR Part 820 knowledge
CMO release process expertise
CAPA and Change Control management
SAP and Smartsolve system proficiency
Nice-to-have
Leadership and mentorship capabilities
Continuous improvement initiative drive
Strong analytical and communication skills
Field Safety Corrective Action experience
Internal audit support experience
Key Requirements
Degree level education or equivalent work experience
Minimum 5 years in Quality Assurance within Medical Device/Pharma
Proficiency in Microsoft Excel, Word, Outlook, and Visio