Your Job
Are you an experienced Quality Engineer looking to take the lead in ensuring medical device excellence? At Phillips Medisize, we are dedicated to developing and delivering life-changing inhalation products. We’re looking for a Lead Quality Engineer (Quality Devices) to provide critical quality support to device development and industrialization, ensuring our products meet the highest standards of safety, compliance, and performance.
What You Will Do
As a Lead Quality Engineer, you’ll play a pivotal role in:
1. Ensuring products are developed, transferred, and manufactured in compliance with industry standards and regulatory requirements.
2. Driving quality excellence that directly impacts patients’ lives worldwide
3. Partner with technical teams to ensure compliance with ISO 13485, ISO 14971, MDR, and FDA QSR requirements.
4. Support and maintain Quality Management Systems.
5. Develop and implement SOPs, protocols, and methods to ensure compliance with internal and external requirements.
6. Perform internal and external audits, following up on non-conformances.
7. Support supplier approval processes and maintain the Approved Supplier List.
8. Manage corrective and preventive actions for both internal and external quality issues.
9. Contribute to quality device KPIs and reporting.
Who You Are (Basic Qualifications)
You’ll bring:
10. Experience in auditing, supplier quality management, and application of ISO 14971 Risk Management.
11. Ability to evaluate/trend dimensional data and interpret technical drawings/specifications.
12. Proven ability to drive improvements in quality systems (complaints, design control, CAPA, risk management, non-conformance).
13. Excellent communication, engagement, and organisational skills.
14. A proactive, calm, and flexible approach in dynamic environments
What Will Put You Ahead
15. Experience in product development and commercial environments, including working with CMOs.
16. Strong knowledge of quality engineering tools (AQQP, SPC, SCAR).
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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