Quality Engineer

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

- 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 and implementation and improvement of the Quality Management System (QMS)
- Works within established procedures covering quality, environmental health and safety, confidentiality and good manufacturing practices

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

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