Quality Admin
About the job
- Ability to identify problems and develop and implement solutions.
- Ability to communicate ideas, arguments, and solutions and work through conflict resolution at all organizational levels, internally and externally.
- Consistently exercise good judgment and comply with corporate ethics guidelines.
- Demonstrate administrative, document-control, and organizational skills.
- Have a college degree or related field.
- Have at least one year of experience in a project administrative assistant, document-control, or coordinator role.
- Be proficient in Excel, Word, and Microsoft Office or PC applications.
- Be able to read and understand specialized English documents.
- Be detail-oriented, dependable, and trustworthy when handling complex and sensitive documents.
- Assist in developing and implementing standards and procedures.
- Administer the product lifecycle management system, including change orders, supplier change notifications, nonconformances, and corrective and preventive actions.
- Scan, file, retain, and control documents and quality records in accordance with Quality System requirements.
- Assist with internal and external audits.
- Contact outside services and coordinate with other departments.
- Assist in completing registration records according to Vietnam regulatory requirements.
- Monitor data quality metrics, coordinate processing of data issues, and propose solutions to improve data quality, including monthly key performance indicators and weekly review of quality events.
- Manage pre-shipment inspection activities and ensure records are accurate and ready for each shipment.
- Administer onboarding training and monitor assigned training.
- Perform other assignments as requested.
- Experience in ISO and/or the medical device industry.
About the company
Nextern designs and manufactures medical devices for equipment makers, with engineering and factory teams involved from early prototypes through production. Its work includes catheter-based instruments and electronic systems used in minimally invasive treatment and diagnostic procedures. Customers pay for development and contract manufacturing services, with project costs shaped by device complexity, materials and production scale. Its clinical markets include vascular and heart interventions and nerve stimulation, with services sold separately or as an integrated program. Founded in 2000 with industrial engineering roots, Nextern shifted to medical devices in 2016 and is headquartered in Maple Grove, Minnesota.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Maple Grove, MN
Founded
2000
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Simplify's Take
What believers are saying
- Advisory broadens the business: Nextern launched dedicated regulatory, clinical and quality consulting services in June 2026.
- New programs expand career scope: Nextern's CEO reported additional programs and staff additions in July 2026.
- Engineers gain leadership scope: Nextern's senior software role specifies smaller-project ownership and mentoring junior engineers.
What critics are saying
- Development programs require patience: Nextern describes medical-device commercialization as taking several months to several years.
- Remote flexibility is limited: Nextern's October 2026 Maple Grove senior software posting explicitly requires on-site work.
- Supply reliability needs daily intervention: Nextern's Vietnam procurement role monitors shortages and negotiates supplier production capacity.
What makes Nextern unique
- Testing simulates living circulation: Nextern's BioSimulation Lab evaluates catheter deployment in a pressurized heart model with physician feedback.
- Interfaces reuse Nextern technology: NextGUI supplies a base software platform for home-use and in-clinic medical devices.
- Prototype access avoids order thresholds: Nextern's NPX division accepts precision-component production work without product minimums.
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Benefits
- Health Insurance
- Dental Insurance
- Health Savings Account/Flexible Spending Account
- 401(k) Retirement Plan
- 401(k) Company Match
- Paid Holidays
- Paid Vacation
- Gym Membership
- Disability Insurance
- Life Insurance
- Training Programs
- Company Social Events