Quality Engineer II

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

Exceptional People. Hard Problems. Meaningful Careers. Big Impact.

Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us.

Job Summary

The Quality Engineer II serves as a member of our production support team for complex electronic and software based medical devices. This role is part of the technical writing, decision making, and customer facing portion of the operations quality team and supports both the New Product Introduction (NPI) and commercial sides of the business. Routine activities fall into the categories of change management, non-conformance management, and partnership with the development teams. Communication and collaboration with customers is required when applicable. This position plays a critical role in incorporating quality into processes and ensuring ongoing compliance with established quality management systems.

Job Duties And Responsibilities

• Author, consult, and approve product and system quality related content to ensure risk-based evaluation of Engineering Change Orders, CAPAs, and planned deviations.
• Complete DHR review and formal written responses to customer feedback / complaints; collaborate on SCAR investigations and development of appropriate corrective and / or preventive actions.
• Review and approve re-work logs and non-conforming material reports, provide or confirm dispositions as required.
• Develop Manufacturing Control Plans, Master Validation Plans, and PFMEAs; support development of Validation / Qualification protocols.
• Collaborate with a variety of engineering organizations to ensure a consistent approach to incorporating compliance to quality management systems within production processes.
• Address manufacturing cell escalations as they are raised through the operations quality organization.
• Identify continuous improvement opportunities to improve the efficiency of quality management system processes.
• Support internal quality audits, as required by the annual schedule.
• Serve as the Quality point of contact with customer organizations, as required.
• Other duties as assigned.

Qualifications And Requirements

• Bachelor’s degree in an engineering, technical, or scientific discipline
• At least 2 years of relevant experience; medical device preferred
• Experience in technical writing & presentation of engineering-based investigations
• High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, Excel, Visio.
• Effective communication skills to provide technical feedback internally and clear guidance / updates to external customers.
• Ability to evaluate risk and impact of changes and non-conforming conditions and make data driven decisions.
• Passionate for change and continuous improvement and embodying a strong sense of urgency.

Working Conditions

• Office and manufacturing environment

Compensation

• The expected starting salary for this position is $80,000 to $95,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program.

EEO Statement

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Employment Requirement

Must be authorized to work in the United States.

Compensation And Total Rewards Package

The salary range for this position is outlined below under "Job Details" and is dependent upon the individual's skills, experience, qualifications, and applicable employment laws. Beyond base salary, Forj offers a competitive Total Rewards Package. We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.