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Quality Assurance Specialist
2 months ago
Job Summary
Insight Global is seeking a highly skilled Senior Quality Consultant to join our team. As a key member of our quality department, you will work closely with our clients to ensure the highest standards of quality and compliance in the development and manufacturing of combination products.
Key Responsibilities
- Collaborate with cross-functional teams to identify and mitigate quality risks
- Develop and implement quality management systems to ensure compliance with regulatory requirements
- Conduct gap assessments and execute remediation plans to improve quality processes
- Provide expert guidance on ISO 11135 and ISO 11067 standards
- Lead notified body audits and ensure compliance with EU MDR regulations
- Develop and maintain quality procedures and documentation
- Provide training and support to internal teams on quality-related topics
Requirements
- Experience in injectables and sterilization, specifically in ETO (Ethylene Oxide) process
- Familiarity with ISO 11135 and ISO 11067 standards
- Notified Body experience in auditing ISO and EU MDR
- QMSR gap assessment and remediation experience
- Experience in both drug and device quality, combination products, preferably injectables
- DHF audits for various phases of devices
- Project remediation experience
What We Offer
At Insight Global, we are committed to creating a diverse and inclusive work environment where our employees can thrive. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
