Quality Engineer - Technical Writer

Flex•Buffalo Grove, IL

2d•Onsite

About The Position

The Quality Engineer - Technical Writer will be based in Buffalo Grove, IL, reporting to Quality Engineer Manager. The Quality Engineer -Technical Writer is responsible for developing, maintaining, and improving technical and quality system documentation in support of FDA and international regulatory requirements. This role partners closely with Quality Engineering and Equipment Engineering to ensure accurate, compliant documentation, with a strong emphasis on risk management activities including FMEA.

Requirements

Bachelor’s degree in Technical Writing, Engineering, Life Sciences, or a related field.
3+ years of technical writing experience in a regulated medical device environment.
Hands‑on experience developing and maintaining FMEAs and risk management documentation.
Working knowledge of: ISO 13485, ISO 14971, FDA 21 CFR Part 820
Experience with electronic document management systems (EDMS).

Responsibilities

Author, edit, and maintain medical device documentation including: Risk management files (ISO 14971), FMEAs (DFMEA, PFMEA, and use‑related risk documentation), SOPs, Work Instructions, and controlled quality documents, Validation and verification documentation
Convert FMEA content from one format to another.
Lead or support FMEA facilitation sessions, ensuring risks are properly identified, documented, and mitigated.
Ensure documentation aligns with regulatory and quality standards (FDA 21 CFR 820, ISO 13485, ISO 14971).
Manage document changes through the document control system, ensuring version accuracy and traceability.
Collaborate cross‑functionally to ensure documentation reflects current processes, designs, and risk controls.
Review and improve documentation processes for clarity, consistency, and compliance.