Equipment Qualification& Software Validation Engineer
Listed on 2026-03-11
-
Engineering
Quality Engineering, Biomedical Engineer
Contract Duration: 12 months – Estimated to end: 3/2027 (Contract Extension Expectation)
Location: 100% ONSITE - Mahwah, NJ (07430)
Work Authorization: Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.
Pay: Negotiable depending on direct-related experience up to $50 - $55 an hour
About the RoleWe are seeking a high-caliber engineer to lead and develop the overall strategy for equipment qualification and software validation, with a particular focus on 2D barcode implementation to ensure EU MDR compliance. This position is strategic in nature, requiring expertise beyond tactical execution and a strong ability to shape validation and compliance approaches for regulated medical device systems.
Key Responsibilities- Spearhead the strategy and execution of 2D barcode projects, including GTIN, UDI, and compliance with EU MDR, GS1, and HIBC labeling requirements.
- Design, author, and implement validation protocols for equipment and software systems in regulated environments (IQ/OQ/PQ, CSV).
- Partner with suppliers to ensure successful validation and qualification of new and existing equipment and labeling systems.
- Lead and manage change control processes for equipment and software systems, driving continuous quality and compliance improvements.
- Coordinate with cross-functional teams and support or lead PPAP (Production Part Approval Process) initiatives.
- Maintain impeccable validation documentation and ensure audit readiness for internal and external inspections.
- 5–10+ years of validation engineering experience in medical devices or related regulated industries.
- Proven expertise designing and executing validation activities for equipment and software.
- Experience with 2D barcode and labeling system implementation (GTIN, UDI, EU MDR, GS1, HIBC) is highly preferred.
- Hands‑on with change control management and quality management systems such as Valgenesis or Track Wise (Valgenesis experience a plus).
- Demonstrated ability to work effectively with suppliers and cross-disciplinary teams.
- Familiarity with PPAP processes.
- Strong analytical, documentation, and communication skills.
To be immediately considered, please send an updated version of your resume to
*** (Kelly does not expense relocation/interview costs)
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).