Quality Engineer
Sriven Systems Inc.
Newark, DE
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JOB DETAILS
JOB TYPE
Temporary, Contractor, Full-time
SKILLS
Corrective Action, Cross-Functional, Mammography, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Organizations, Process Analysis, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Project/Program Management, Quality Engineering, Quality Management, Regulations, Risk, Risk Analysis, Root Cause Analysis, System Validation, Validation Plan
LOCATION
Newark, DE
POSTED
17 days ago
Role: Manufacturing / Quality Engineers – Medical Device (Onsite)
Location: Newark, Delaware 100% on site.
Duration: 6 - 12 months contract
Overview
We are partnering with a leading medical device organization to build out a high-impact engineering team supporting their flagship mammography systems. This is a critical initiative focused on strengthening the foundation of their Quality Management System and driving validation excellence across manufacturing operations.
Must-Have Background
- 4–5+ years medical device experience (minimum)
- Engineering degree required (Mechanical, Biomedical, Industrial, etc.)
- Experience at established med device companies (e.g., Stryker, J&J, etc.)
- Prior remediation experience strongly preferred
- Strong validation and TMV experience
Day to Day
- Review and enhance existing PFMEAs, identify missing failure modes and risk gaps, strengthen mitigations and ensure appropriate controls are in place (PFMEA assessment, development, and remediation).
- Conduct thorough process risk analysis, drive root cause investigations and implement corrective actions.
- Lead and execute validation activities (IQ/OQ/PQ), develop and defend validation strategy and protocols, execute and document TMV activities
- Manage deviations, link risks appropriately, and ensure regulatory alignment
- Collaborate cross-functionally with manufacturing, quality, and program management stakeholders
About the Company
S
Sriven Systems Inc.
INDUSTRY
Biotechnology/Pharmaceuticals