Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. We leverage a long-standing experience to provide our clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing.

Overview:

• Manages all quality aspects within assigned projects such as: compliance with applicable norms and regulatory requirements, risk management, design verification, validation, design history file, design change control, CAPAs, and design transfer
• Develops and utilizes quality tools within the Chicago Innovation Center
• Supports the development and implementation and improvement of the Quality Management System (QMS)
•  Work within defined procedures for development including quality, environmental health and safety requirements, confidentiality, and good manufacturing practices

Responsibilities:

• Supports and challenges project team on all aspects of quality
• Approves relevant project documentation per approved development procedure checklists
• 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
• Participates in the creation of, and ensures completion of, design control documentation for product development programs
• Ensures quality of program documentation, including traceability
• Ensures quality of the developed products

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 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 skills
• Excellent interpersonal and organization skills

All your information will be kept confidential according to EEO guidelines.

PAY RANGE: $90,000 - $130,000 USD Annual Salary 

For US Benefits, CLICK HERE.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.