EDHR Reviewer - One Factory

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.

Job Summary

At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.

Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people’s lives.

Job Summary

As an EDHR Reviewer - One Factory, you'll play a critical role in ensuring products are accurately documented, compliant, and ready for release to customers. In this position, you'll work closely with Quality, Manufacturing, Operations, and Customer teams to review and approve Electronic Device History Records (EDHRs), support batch record documentation, and help drive timely product releases. This role offers the opportunity to become a subject matter expert in medical device documentation and regulatory compliance while making a direct impact on product quality and patient safety. If you enjoy detail-oriented work, cross-functional collaboration, and contributing to a highly regulated manufacturing environment, this is an excellent opportunity to grow your quality and medical device expertise.

What a typical day looks like

• Review, verify, and approve Electronic Device History Records (EDHRs), batch records, and supporting documentation to ensure compliance with internal procedures, customer requirements, and regulatory standards.
• Partner with Manufacturing, Quality, Order Management, and Operations teams to resolve documentation issues, support nonconformance and CAPA investigations, and ensure timely product release.
• Serve as a resource for EDHR processes by providing guidance on documentation requirements, record accuracy, and process improvements.
• Compile quality documentation, retrieve data from quality systems, prepare reports, charts, and status updates, and communicate progress to internal stakeholders and customers as needed.
• Support final product release activities, provide quality documentation support to manufacturing lines, and assist with in-process and finished goods review activities

The experience we are looking for

• High School Diploma or equivalent required.
• Technical training, quality certifications, or experience supporting FDA and/or ISO-regulated environments is preferred.
• Typically requires 4+ years of related quality, manufacturing, documentation, or regulatory compliance experience.
• Strong attention to detail with the ability to review, analyze, and verify complex manufacturing and quality documentation.
• Experience working in a regulated manufacturing environment, preferably within medical device, pharmaceutical, life sciences, or other highly controlled industries.
• Knowledge of quality systems, documentation control, device history records, batch records, CAPA, nonconformance investigations, and regulatory compliance requirements.
• Ability to interpret specifications, procedures, charts, tables, and technical documentation with a high degree of accuracy.
• Familiarity with quality tools and methodologies such as SPC, FMEA, Control Plans, and 8D problem solving.
• Proficiency with Microsoft Office applications including Excel, Word, and data management systems.
• Strong communication and collaboration skills with the ability to work effectively across Quality, Manufacturing, Operations, and Customer-facing teams.

What you'll 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

Application Deadline:

Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume.

The base pay range for this position is provided below. The final base rate offered will be determined using job-related, non-discriminatory criteria, including but not limited to experience, qualifications, geographic location, education, external market data, and internal equity.

$21.61 USD - $29.18 USD Hourly

Job Category

Quality

Is Sponsorship Available?

No

Flex 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. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll 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).