Distribution Quality Assurance Specialist
$65,900–$103,000 year
On-siteNewark, Delaware, United States
Newark, Delaware, United StatesOn-siteFull Time$65,900–$103,000 yearBachelors DegreeHealthcare TechLarge
Full TimeBachelors DegreeLargeHealthcare Tech
Job Summary
Assess, qualify, and manage Distribution Service Providers including 3PLs and distributors to ensure product integrity throughout distribution channels. Oversee compliance documentation, participate in audits, and lead root cause analysis, risk assessments, and CAPA initiatives aligned with U.S. FDA regulations and ISO standards. Collaborate cross-functionally to drive continuous improvement and maintain alignment with internal quality system requirements. Requires proficiency in FDA regulations, logistics processes, and PLM/ERP systems, with a minimum of three years in medical device quality.
Required Qualifications
- Proficient understanding of U.S. FDA regulations (21 CFR Parts 11 and 820)
- ISO 13485
- medical device quality systems
- root cause analysis
- risk assessment
- CAPA (Corrective and Preventive Actions)
- auditing
- logistics and distribution processes
- Bachelor's Degree in Engineering, Quality Assurance, Supply Chain Management, Logistics, or a related field
- Minimum of 3 years' experience in medical device manufacturing or a related industry
- Quality function
- Experience supporting FDA inspections and internal/external audits
Desired Qualifications
- knowledge of Power BI and AI tools
- advanced degree
- Experience with logistics and distribution processes is highly preferred
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