Kasmo Global
ROLE RESPONSIBILITIES
- Supports the maintenance of Medical Device and Combination Products Quality Management Systems including remediation and continual improvement.
- Development, implementation, and monitoring of Quality and Regulatory Compliance strategies for medical devices and combination products.
- Supports inspection readiness and compliance with all applicable medical device and combination product regulations within the scope of the manufacturing site's activities.
- Provides SME support during Regulatory/Customer audits for products and Medical Devices including contributions to strategies to successfully respond to auditor concerns.
- Contributes to quality systems improvement plans. .
- Provides support for Medical Device & Combination Product Internal & External Audits and regulatory inspections, participates in internal GMP audits.
- Authors, reviews, and / or approves GMP related SOPs and documents.
- Supports technical execution of Design History File (DHF) enhancements / updates.
- Bachelor's degree in Chemistry, Biochemistry, Engineering, Life Science or other technical/scientific degree.
- Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820 and Part 4), ISO 13485:2016 and ISO 14971 requirements and related standards.
- A minimum 5 years' experience in Medical Device or Combination Products Quality, Design Controls, Production, or related field.
- Minimum 5 years of experience in a Quality Engineering, Quality Assurance role