Quality Engineer II – Medical Devices, NPI & Compliance

Forj Medical; Saint Paul (MN); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

Annual bonus

Job summary

Forj Medical in Minnesota is seeking a Quality Engineer II to join the production support team for complex electronic and software based medical devices. This role participates in change management, non-conformance handling, and collaboration with development teams to ensure compliance with quality systems.

The ideal candidate will have a bachelor’s degree in engineering or a related field, 2+ years of relevant medical device experience, strong technical writing skills, and proficiency with

Qualifications

• Bachelor’s degree in engineering, technical, or scientific discipline.
• At least 2 years of relevant experience; medical device preferred.
• Experience in technical writing & presentation of engineering investigations.
• High proficiency with Outlook, Word, PowerPoint, Excel, Visio.
• Effective communication to provide technical feedback and updates.

Responsibilities

• Author, consult, and approve product and system quality content for ECOs, CAPAs, and deviations.
• Review and respond to customer feedback/complaints; support SCAR investigations.
• Review non-conforming material reports and determine dispositions.
• Develop Manufacturing Control Plans and PFMEAs; assist with validation protocols.
• Collaborate with engineering teams to ensure quality system compliance in production.
• Address manufacturing escalations within the operations quality group.
• Identify continuous improvement opportunities in quality processes.
• Support internal quality audits and customer-facing quality activities.
• Serve as quality contact with customer organizations as needed.

Skills

Technical writing

Investigations

Communication skills

Risk assessment

Education

Bachelor’s degree in engineering/technical/scientific field

Tools

Outlook

Word

PowerPoint

Excel

Visio

Job description

Forj Medical in Minnesota is seeking a Quality Engineer II to join the production support team for complex electronic and software based medical devices. This role participates in change management, non-conformance handling, and collaboration with development teams to ensure compliance with quality systems.

The ideal candidate will have a bachelor’s degree in engineering or a related field, 2+ years of relevant medical device experience, strong technical writing skills, and proficiency with