Quality Engineer(Direct Hire)
Vernon Hill, IL (hybrid)
Job Requisition:6891
Description for Quality Engineer:
The Quality Engineer is responsible for coordinating and verifying quality standards in accordance with the requirements of the organization.
Responsibilities forQuality Engineer:
- 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.
- Develop and implement process flows in cooperation with functional groups.
- Create Metrics that drive effective monitoring of processes, value-add improvements and communication at all levels of the organization.
- Responsible for identifying and leading improvement projects.
- Organize investigation activities and coordinate appropriate resources to drive for root cause determinations, correction action implementation and effectiveness verification.
- Ensure risk assessment activities are executed and maintained according to regulatory standards.
- Responsible for the validation of all required manufacturing processes in compliance with applicable internal and external requirements.
- Coordinate manufacturing process validation requirements, documentation and maintenance of validated processes with internal and external stakeholders.
- Perform validation training.
- Provide reports and data on assigned metrics.
- Create and update applicable procedures, work-instructions, forms, and other documentation as needed.
- Participate and support the ECO, CAPA, MRB and other Quality System processes.
- Provide 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.
Requirements forQuality Engineer:
- B.S. Degree in applicable technical discipline such as mechanical or bio-medical engineering (will consider candidates without a degree with strong industry experience).
- 3-5 years’ experience in Medical Device industry highly preferred.
- Requires experience with manufacturing validations (IQ/OQ/PQ) or related experience.
- Relevant 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 & Statistical Process Control.
- Excellent communication skills.
- Advanced PC knowledge and working experience with spreadsheets, presentations and report writing tools.
