Quality Engineer

Now is our time to inspire the future of healthcare together.

Our client is a leading global medical technology company with over 170 years of heritage and more than 18,000 patents. With over 68,000 dedicated colleagues across more than 70 countries, they are committed to shaping the future of healthcare. We collaborate closely with customers worldwide to support the delivery of high-quality care to patients. Every day, an estimated 5 million patients benefit from our innovative technologies and services in diagnostic and therapeutic imaging, laboratory diagnostics, molecular medicine, digital health, and enterprise services. This is what truly drives us.

We are currently seeking a Quality Engineer to join our client's team within the Point of Care Diagnostics business line.

The Quality Operations Engineer will be responsible for maintaining, monitoring, and enhancing key elements of the Quality Management System (QMS) at the Sudbury Site. This role will foster a culture of quality through education, mentoring, and leading by example.

Key Responsibilities:

• Provide quality support to the Manufacturing Operations Team.
• Support CAPA and issue resolution to ensure timely and accurate completion.
• Administer and support the deviation process, ensuring timely and precise completion.
• Manage and support the quality notification process for timely and accurate outcomes.
• Prepare for supplier, customer, regulatory, and notified body audits as required.
• Conduct internal and supplier quality audits as necessary.
• Support the change control process.
• Prepare, review, and approve or reject quality-related documentation.
• Deliver training support on key aspects of the Quality Management System.
• Generate quality-related metrics, reports, and KPIs; lead improvement projects and quality initiatives.
• Participate in SQDIP meetings, providing accurate and timely reports; take ownership of achieving target KPIs for the role.
• Utilise business systems such as CATSWEB, CERDAAC, SAP, Documentum, and Learn4U effectively.

Regulatory Requirements

• Represent the business during customer audits and regulatory inspections, demonstrating compliance with systems.
• Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11, and applicable regulatory guidelines.

Environment, Health and Safety (EHS)

• Ensure compliance with safety, health, and environmental (SHE) legislation.
• Promote a safety-first culture, striving for zero accidents; ensure adherence to accident prevention and environmental protection regulations to maintain a safe, productive workplace free from liabilities or defects.

Teamwork and Collaboration

• Engage with project teams to support the selection, installation, and commissioning of new equipment.

Quality Assurance

• Demonstrate competence in the principles and practical application of Quality Management Systems.

Skills and Experience

• Proven ability to manage time effectively with a strong desire to succeed.
• Flexible and adaptable approach to changing workloads.
• Self-motivated, reliable, and capable of working independently.
• Effective team player with excellent communication skills across functions.
• Curious and eager to learn, with strong written and verbal communication skills.

Qualifications

• Minimum of five years' experience in a medical manufacturing environment.
• Comprehensive knowledge of Quality Management Systems, ISO 13485, and 21 CFR 820.
• Proficient IT skills with strong knowledge of Microsoft Office applications.
• Familiarity with GDP and GMP (Good Documentation Practises and Good Manufacturing Practises).

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