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Design Assurance Quality Engineer
Job in
Scranton, Lackawanna County, Pennsylvania, 18512, USA
Listed on 2026-05-31
Listing for:
United Pharma
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
We are seeking a Design Assurance Quality Engineer to support product development initiatives for an innovative medical device organization
. This role focuses on ensuring quality and regulatory compliance throughout the design and development lifecycle.
- Provide Design Assurance and Quality Engineering support for product development activities
- Review and support material specifications, drawings, inspections, and manufacturing SOPs
- Ensure compliance with quality systems and regulatory standards
- Lead activities related to metrology, inspection systems, and non-conformance management
- Support risk management, CAPA, root cause analysis, and QA planning
- Review design transfer and tech transfer documentation for compliance
- Participate in cross-functional meetings and maintain accurate, compliant documentation
- 6+ years of experience in medical device quality assurance
, with strong design assurance background - Solid knowledge of 21 CFR 820, ISO 13485, and related quality standards
- Hands-on experience with FMEA, SPC, Minitab, and risk-based methodologies
- Bachelor’s degree in Engineering or related field
- Strong communication and stakeholder management skills
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