Nextern

Designs and manufactures medical devices

Principal Quality Assurance Engineer

Quality EngineeringPosted on Nov 6

Full-timeMaple Grove, MN, USA$130k - $170k

About the Job

Requirements

A Bachelor’s degree (BS) in an engineering discipline or an equivalent combination of education and experience is required.
At least 10 years of experience in medical device manufacturing is required.
Experience working in quality systems defined by 21 CFR 820 and ISO 13485 is required.
Expert-level knowledge and application of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is required.
An intimate understanding of ISO 14971 and application of risk management principles is required.
Demonstrated technical expertise and leadership in quality is required.
High attention to detail, organization, and accuracy is required.
The candidate must be capable of creative thinking and proposing novel solutions.
Strong written and verbal communication across disciplines and organizational structures is required.
Demonstrated use of quality tools and methodologies, including nonconformance, corrective and preventive actions (CAPAs), and root cause analysis, is required.
Familiarity with common statistical software, such as Minitab, is required.
Experience with Product Lifecycle Management (PLM) software, such as Windchill, Agile, or Propel, is required.
Intermediate to advanced proficiency with Microsoft Office Suite applications, including Word, Excel, PowerPoint, Project, and Outlook, is required.
The role requires the ability to support U.S. manufacturing primarily and global manufacturing sites as needed, up to 10%.

Responsibilities

Support manufacturing and device quality for commercial devices and manufacturing transfers.
Own sustaining activities for investigational and commercial device manufacturing, including changes, audits, nonconformances, corrective and preventive actions, and complaint investigations, ensuring timely completion.
Ensure compliance with the Quality System and relevant regulations and standards, contribute to continuous improvement, and interact professionally with customers as needed.
Serve as a Phase 4–5 project core team member accountable for product development deliverables, including process risk assessments (PFMEA), Master Validation Plans and Reports, failure and scrap code identification and maintenance in alignment with process risks, and manufacturing, process monitoring, and product acceptance plans.
Draft, collaborate on, and approve project deliverables and engineering work orders.
Coordinate and execute process output testing for verification and validation, as necessary.
Create and maintain up-to-date product Device Master Records (DMR).
Compile, analyze, and present product-specific quality metrics for various review forums.
Own manufacturing and Device History Record (DHR) review as part of complaint investigations.
Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Proactively identify redundancy and opportunities to improve Quality System requirements.
Own, review, and approve changes, ensuring impacts and resulting actions or implementation decisions are properly documented and executed.
Identify, own, and execute nonconformance investigations and implement corrective and preventive actions, as necessary.
Support audits as a subject matter expert (SME) for Quality Management System (QMS) processes and product line manufacturing.
Lead Product Lifecycle Management (PLM) architecture and changes, as needed.

Desired Qualifications

A secondary certification in Quality, such as CQE or CQA, or in lean principles, such as Six Sigma, is preferred.

Principal Quality Assurance Engineer

Nextern · Maple Grove, United States · Full-time · Posted 2026-11-06

Salary: USD 130,000–170,000

Workplace: on_site

Department: Quality Assurance

Description

Please note - No sponsorship or transfer of sponsorship is available for this role, including but not limited to OPT and H-1B

At Nextern, we inspire with passion, impact with significance, and act with integrity. Nextern partners with OEMs, clinicians, and innovators to design, develop, and manufacture world-class medical devices across the full product lifecycle. From single-use disposables to fully integrated systems to precision components, our teams work as an extension of yours to solve patient needs and improve lives worldwide.

This role is responsible for manufacturing and device quality for commercial devices and manufacturing transfers. Quality engineers own sustaining activities for investigational and commercial device manufacturing, such as changes, audits, nonconformances, CAPAs, and complaint investigations ensuring timely completion of activities. All engineering functions are responsible for compliance with the Quality System and relevant regulations and standards, continuous improvement, and as needed, professional interaction with Nextern Customers.

RESPONSIBILITIES

Primarily supports US manufacturing, but may support global manufacturing sites up to 10%
Phase 4-5 Project core team member accountable for product development deliverables including, but not limited to: Process risk assessment (PFMEA); Master Validation Plan(s) and Report(s); Failure/Scrap code identification and maintenance in alignment with process risks; Manufacturing, process monitoring, and product acceptance plans
Draft, collaborate, and approve project deliverables and engineering work orders
Coordinate and execute, as necessary, process output testing (verification/validation)
Create and maintain up-to-date product Device Master Records (DMR)
Compile, analyze, and present product specific Quality metrics for various review forums
Own manufacturing/DHR review as part of complaint investigations
Lead by example in Good Manufacturing Practices (GMP) and Good Documentation Practices (GMP)
Proactively identify redundancy and opportunities for improvement in Quality System requirements
Own, review, and approve changes ensuring impacts and resulting action/implementation (or lack thereof) are properly documented and executed
Identify, own, and execute nonconformance investigations and implementation of corrective and preventive actions, as necessary
Support audits as Subject Matter Expert (SME) for QMS processes and product line manufacturing
Lead Product Lifecycle Management (PLM) architecture and changes, as needed

Requirements

QUALIFICATIONS

Required:

Bachelor's Degree (BS) in engineering discipline or equivalent combination of education and experience.
10+ years of experience in medical device manufacturing
Success working in quality systems as defined in 21 CFR 820 and ISO 13485.
Expert level knowledge and application of GMP, GDP
Intimate understanding of ISO 14971 and application of risk management principles
Demonstrated technical expertise and leadership in quality
High attention to detail, organization, and accuracy
Instinctual capability for creative thinking and proposing novel solutions
Strong ability to communicate (written and verbally) within and across disciplines and organization structures
Demonstrated use of quality tools and methodologies (e.g. nonconformance, CAPAs, root cause analysis, etc..)
Familiarity with common statistical software, such as Minitab
Experience with Product Lifecycle Management (PLM) software (e.g Windchill, Agile, Propel)
Intermediate to advanced proficiency with MS Office Suit (Word, Excel, PowerPoint, Project, Outlook).

Preferred:

Secondary certification in Quality (e.g. CQE, CQA) or lean (e.g. six sigma) principles preferred

Salary range: $130,000 to $170,000 based on skills and experience

Benefits

Health Care Plan (Medical, Dental & Vision)
Retirement Plan with Company Match
Paid Time Off, Personal Days, AND Birthday Holiday!
Lifetime Membership Subsidy and Wellness Resources
Life Insurance (Basic, Voluntary & AD&D)
Family Leave (Maternity, Paternity)
Short-Term & Long-Term Disability
Taco Thursdays!!!

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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About the Company

Nextern

Designs and manufactures medical devices

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: Not listed
Total funding: Not listed
Headquarters: Maple Grove, MN
Founded: 2000

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