Description

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.


BASIC QUALIFICATIONS

  • 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

Key Skills
Education

Any Graduate

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