Posting Date: 05/02/2025

POSITION:          
Sr. Quality Engineer

Full-time job, 40 hours per week
Pay/Salary: $102,814.00 year.

 
NUMBER OF OPENINGS:
3

 
LOCATION:
Cloudinfo Inc
1000 N. West Street, Suite 1263
Wilmington, DE 19801

JOB DUTIES:
· Provide Quality compliance input to the project team for project deliverables including Product Specifications, Risk Files, Design Reviews, V&V, Design Transfer, Clinical Evaluation Plans/Reports and demonstrating commitment to patient safety and product quality.

· Perform document reviews as Quality Reviewer to support EU MDR project activities including design and labeling change controls.

· Utilizing engineering and quality tools/methodologies Six Sigma-DMADV DMAIC to investigate complex and diverse product technical product problems and develop solutions which require critical, analytical, and creative thinking.

· Provide Quality reviews and approve overall DHF documentation including CRD, DRD, Trace Matrix, Standard Analysis, Design Verification Validation Summary Report, Risk Management documents, Clinical deliverables CER, CEP, BER and PMS activities including PMSP, PMSR, PMCFP, PMCFER, PSUR, SSCP and STED, GSPR documents in Team Centre Unified (TcU).

· Performing assessment of nonconformance and containment activities throughout lifecycle of nonconformance record using Trackwise.

· Work under supervision and Travel and/or relocation to unanticipated client sites throughout USA is required.

 
EDUCATION:
Master’s degree in Mechanical Engineering or closely related field with Twelve (12) months of experience in the job offered or as a Validation Engineer or Quality Engineer or related field.

 
EXPERIENCE:
Experience of Twelve (12) months working as a Validation Engineer or Quality Engineer or closely related field is required. Travel and/or relocation to unanticipated client sites throughout USA is required.