Quality Engineer - Technical Writer

Flex • Buffalo Grove, IL

19h • Onsite

About The Position

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. The Quality Engineer - Technical Writer will be based in Buffalo Grove, IL, reporting to the 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.

Benefits

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) Contributions
• Vacation and Paid Sick Time
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees