- Remote work flexibility
- Strong employee focused leadership team
About Our Client
Our Clients is a medical device manufacturer located in Vernon Hills. They are looking for a passionate Validation Engineer to join their team. This client is an industry leader in the medical device space as a manufacturer of endoscopic equipment. They boast an inclusive company culture centered on communication and cross functionality.
- Responsible for the validation of all required manufacturing processes in compliance with applicable internal and external requirements.
- Coordinates manufacturing process validation requirements and documentation with internal and external stakeholders.
- Supports the update and maintenance of validated processes
- Supports validation training.
- Builds, organizes, and maintains databases and/or logs of actions completed, pending actions, and current status
- Provides reports and data on assigned metrics.
- Creates and updates applicable procedures, work-instructions, forms, and other documentation as needed.
- Participates and supports ECO, CAPA, MRB and other Quality System processes
- Provides documentation and support during audits.
- Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
- Manages multiple, often concurrent projects and meets deadlines.
- Coordinates acquisition of cross-functional resources.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
- B.S. Degree in applicable technical discipline, such as mechanical, bio-medical or chemical engineering, required
- Relevant experience or certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS) preferred
- Applied understanding of statistical methods and tools, such as Six Sigma & Mini Tab required.
- Excellent communication skills.
- Advanced PC knowledge and working experience with spreadsheets, presentations and report writing tools.
What's on Offer
- Competitive Base Salary: 75,000 to 95,000
- 401K: 50% on the dollar up to 4%
- Time off
- 10 days of vacation
- 10 days of sick
- Holidays: 6 majors + 3 Extra + 2 Holidays