Quality Engineer Technical Writer
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Job Location:
Buffalo Grove, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Summary
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.
What a typical day looks like:
- Author edit and maintain medical device documentation including:
- Risk management files (ISO 14971)
- FMEAs (DFMEA PFMEA and userelated 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 crossfunctionally to ensure documentation reflects current processes designs and risk controls.
- Review and improve documentation processes for clarity consistency and compliance.
The experience were looking to add to our team:
- Bachelors degree in Technical Writing Engineering Life Sciences or a related field.
- 3 years of technical writing experience in a regulated medical device environment.
- Handson 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).
What youll receive for the great work you provide:
- 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
Job Category
QualityIs Sponsorship Available
NoFlex is an Equal Opportunity Employer and employment selection decisions are based on merit qualifications and abilities. We do not discriminate based on: age race religion color sex national origin marital status sexual orientation gender identity veteran status disability pregnancy status or any other status protected by law. Were happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and well discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex you must complete the application process first).Required Experience:
IC
About Company
Flex is the manufacturing partner of choice for streamlined product lifecycles. From design to end of life, our end-to-end services optimize efficiency.
