Quality Engineer

Nemera • Chicago, IL

6h • Onsite

About The Position

Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. They leverage a long-standing experience to provide clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing. The Quality Engineer 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), and supports additional quality activities such as design controls, risk management, verification and validation, design changes, and design transfer. This role also involves developing and utilizing quality tools within the Chicago Innovation Center and supporting the development, implementation, and improvement of the Quality Management System (QMS). The engineer 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees