Sr. Quality Engineer
Listed on 2026-07-01
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Quality Management Specialist
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
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