Now is the time to inspire the future of healthcare together.
Our client is a leading global medical technology company with over 170 years of expertise and 18,000 patents. More than 68,000 dedicated colleagues across 70 countries are committed to shaping the future of healthcare. We stand alongside our customers worldwide, supporting them in delivering exceptional care to their patients. Every day, approximately five million patients benefit from our innovative technologies and services in diagnostic and therapeutic imaging, laboratory diagnostics, molecular medicine, digital health, and enterprise services. This commitment is at the heart of everything we do.
Join our client's team as an IQA Technician within the Point of Care Diagnostics business unit.
Role Overview The IQA Inspector is responsible for inspecting, controlling, and approving all incoming materials at the Sudbury manufacturing sites. This includes completing all relevant documentation and ensuring traceability in line with applicable quality standards. The IQA Inspector guarantees that all materials used in production meet stringent quality requirements.
Key Responsibilities Inspect incoming goods across Sudbury sites using measurement equipment, specifications, and Quality Control Plans (QCPs), ensuring full compliance before assembly.
Complete all associated documentation and records, adhering to Good Documentation Practises (GDP).
Contribute to the control and disposition of non-conforming materials, including segregation and documentation, following established procedures.
Communicate effectively with internal and external suppliers and stakeholders; act as the primary point of contact for part quality enquiries and escalate issues as necessary.
Complete all assigned training within specified timeframes.
Support other Quality functions at Sudbury, including in-process testing, inspections, and final product release processes.
Assist with internal and third-party site audits.
Participate in SQDIP meetings, provide accurate reports promptly, and take ownership of achieving role-specific KPIs.
Maintain supplier ‘Quality Approved' samples for relevant attributes such as colours and finishes.
Utilise business systems including CATSWEB, CERDAAC, SAP, Documentum, and Learn4U efficiently.
Regulatory Compliance Represent the business during customer audits and regulatory inspections, demonstrating compliance with required systems.
Maintain adherence to Data Integrity Regulations, GAMP standards, 21 CFR Part 11, and other relevant regulatory guidelines.
Environmental, Health and Safety (EHS) Ensure compliance with safety, health, and environmental (SHE) legislation.
Promote a safety-first culture by maintaining a zero-accident environment, preventing accidents, and protecting the facility's environmental standards.
Teamwork and Quality Assurance Collaborate with project teams to support the selection, installation, and commissioning of new equipment.
Apply knowledge of Quality Management Systems with competence and practical understanding.
Skills and Experience Proven ability to manage time effectively, demonstrating a strong drive to succeed.
Flexible and adaptable approach to varied workloads.
Self-motivated and reliable, able to work independently and take initiative.
Effective team player with strong cross-functional communication skills.
Curious and eager to learn, with excellent written and verbal communication abilities.
Qualifications Minimum of five years' experience in a medical manufacturing environment.
In-depth knowledge of Quality Management Systems, ISO 13485, and 21 CFR 820.
Proficient in IT, with strong skills in Microsoft Office applications.
Familiarity with Good Documentation Practises (GDP) and Good Manufacturing Practises (GMP).
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