Validation EngineerQuality Systems Engineer
Vernon Hills, IL - USA
Job Summary
My client is a medical device company seeking a Validation Engineer to own the full validation lifecycle - from writing and executing protocols to maintaining the calibration system and supporting regulatory compliance. This role sits at the intersection of Quality Systems and engineering and is central to the companys ability to bring compliant high-quality products to market.
Why You Should Apply
- Broad scope - own validation calibration and quality systems work across the organization
- Direct impact on regulatory compliance for a growing medical device company
- Cross-functional visibility - partner with engineering manufacturing and quality leadership
- Salary range: $90000 - $100000
- Full benefits package including medical dental vision and 401k
What Youll Be Doing
- Write execute and maintain validation protocols for manufacturing equipment processes and systems
- Manage the calibration system and equipment database
- Analyze validation data and identify nonconformities; recommend and track corrective actions
- Support design controls CAPA change control and post-market surveillance activities
- Review DHF deliverables and provide FDA compliance guidance
About You
- Be able to do the job as described
- Knowledge of ISO 13485 ISOCFR Part 820 and EU-MDR
- Experience with process and test method validations in an FDA-regulated industry
- Background in medical device or pharmaceutical manufacturing
- Blow-Fill-Seal experience is a plus
This is a full-time permanent direct-hire opportunity. My client is unable to provide visa sponsorship now or in the future. Applicants must be authorized to work in the United States without sponsorship.
How To Apply
Wed love to see your resume but we dont need it to have a conversation. Email Cat at and tell me why youre interested. Or if you do have a resume ready apply here.
Required Experience:
IC
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.