Quality Engineer

Nemera•Chicago, IL

18h•Onsite

About The Position

Ensures compliance with applicable standards and regulatory requirements (e.g., FDA, ISO). Manages manufacturing quality operations supporting the production lifecycle (e.g., DHR, batch release, risk-based controls). Supports additional quality activities such as design controls, risk management, verification and validation, design changes, and design transfer. Develops and utilizes quality tools within the Chicago Innovation Center. Supports the development, implementation, and improvement of the Quality Management System (QMS). Works within established procedures covering quality, environmental health and safety, confidentiality, and good manufacturing practices.

Requirements

Bachelor’s or Master’s degree in Engineering, Science or related field
3+ years of experience working in quality departments for the regulated industries of pharmaceutical or medical device
Working knowledge of relevant regulations and industry standards (FDA 21 CFR 820, ISO 13485, etc.)
Experience leading validation and documentation efforts within a manufacturing environment
Experience working on design control and risk management documentation for medical devices/combination devices/pharmaceuticals
Familiar with basic statistics, Gage R&R, Design of Experiments
Self-motivated with good communication and organization skill

Responsibilities

Supports and challenges project team on all aspects of quality
Reviews and approves quality documented in accordance with development procedures
Leads validation activities and ensures completion of DHR deliverables
Participates in project risk management activities ensuring that tools such as the Risk Management Plan, Risk Management Report and FMEA are properly used (product and process de-risking).
Follows up and reports project status regularly to the Unit Quality Manager
Participates in internal audits
Actively participates in the QMS maintenance and improvement
Ensures quality of program documentation, including traceability
Ensures quality of the developed products