Sr. Quality Engineer

Job Title

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