Senior Quality Engineering Manager

Forj Medical; Saint Paul (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Dental benefits

Vision benefits

401(k) plan

Time-off programs

Annual bonus program

Job summary

Forj Medical in Saint Paul, Minnesota, is looking for a Senior Quality Engineering Manager to spearhead a quality engineering team. This role involves overseeing quality assurance processes for manufacturing, managing and developing a team, and ensuring compliance with regulatory standards such as FDA 21 CFR 820 and ISO 13485. Ideal candidates will have at least 10 years of experience in quality control within a medical device environment and strong leadership skills. A competitive compensation package including health benefits is offered.

Qualifications

• 10+ years of relevant experience in quality assurance, quality control, and quality systems.
• Experience managing direct reports and promoting a culture of accountability.
• Experience with FDA 21 CFR 820 and ISO 13485 regulations.

Responsibilities

• Lead a team of quality engineers supporting manufacturing operations.
• Define and monitor quality key performance indicators.
• Oversee nonconformance management processes.

Skills

Quality assurance

Quality control

Leadership

Critical thinking

Process improvement

Education

Bachelor’s degree in engineering, technical, or scientific discipline

Tools

Lean tools

Six Sigma tools

Microsoft Office Suite

Job description

Job Summary

The Senior Quality Engineering Manager is responsible for leading the team of quality engineers supporting manufacturing operations. The Quality Engineering team scope spans the areas of change management, nonconformance management, and late-stage development deliverables as projects move from design stage to commercial launch. The incumbent ensures the consistent delivery of devices that meet customer specifications by driving accountability to quality KPIs and monitoring quality system compliance and health. They also provide tactical leadership of the QE team by giving guidance on prioritization and handling escalations, fostering effective cross‑functional collaboration, and developing each engineer’s skill set to further their growth as a quality professional.

Team Leadership & Talent Development

• People Management: Direct supervision of quality engineers, managing workload distribution, conducting performance reviews, and establishing clear accountability for individual and team goals.
• Coaching & Mentoring: Architect professional development plans for the QE team, focusing on technical skill building (risk‑based thinking, root cause analysis) and soft skills (conflict resolution, cross‑functional collaboration).
• Prioritization & Escalation: Serve as the primary point of contact for escalations within quality engineering, providing support for customer interactions and tactical guidance to ensure production hurdles are cleared without compromising quality.

Quality System Oversight & Compliance

• KPI Management: Define, monitor, and report on quality key performance indicators indicating quality system process health; analyze technical data to identify continuous improvement opportunities.
• Compliance Leadership: Maintain the health of the Quality Management System (QMS) in accordance with FDA 21 CFR 820 and ISO 13485, ensuring that the site is always in a state of audit readiness.
• Audit Representation: Act as a subject matter expert and spokesperson for Quality Engineering as needed during internal audits and external regulatory inspections.

Manufacturing Operations Support

• Nonconformance Management: Oversee nonconforming material processes from material receiving through final device inspection, ensuring that nonconformances are investigated thoroughly, root causes are identified, and dispositions are risk‑assessed and justified.
• Change Control: Direct the quality review of engineering change orders (ECOs) and deviation authorizations (DAs) ensuring that permanent and temporary changes to processes, components, and/or equipment are appropriately evaluated, controlled, and documented.

New Product Transfer & Late‑Stage Development

• Design Transfer: Supervise the QE team through the transition of products from R&D to commercial manufacturing, ensuring that design transfer deliverables—including inspection methods and production controls—are robust.

Cross‑Functional Collaboration & Strategy

• Strategic Relationship Management: Communicate effectively with senior leadership regarding quality risks and resource needs; collaborate with Production, Supply Chain, and Engineering heads to align on business priorities.
• Process Improvement: Champion a culture of continuous improvement by deploying Lean and Six Sigma tools to streamline quality processes.
• Startup Agility: Adapt quality workflows to suit a fast‑paced, evolving business environment while maintaining regulatory compliance and ensuring patient safety. Maintain a high level of technical fluency, remaining willing to provide hands‑on support for customers and deliverables.

Requirements

• Bachelor’s degree in an engineering, a technical, or a scientific discipline.
• 10+ years of relevant experience including quality assurance, quality control, and/or quality systems in a manufacturing environment; preferred experience as a quality professional in a medical device–manufacturing firm.
• Experience effectively managing direct reports, including team upskilling through coaching and mentoring and promoting a culture of accountability.
• Strong leadership skills: clear communication, detail orientation, critical thinking, and confident decision making.
• Experience navigating a business experiencing rapid change (e.g., startups, acquisitions).
• Relationship management: Proven capability to manage up, develop customer relationships, and drive team engagement.
• Experience with regulated environments (FDA 21 CFR 820, ISO 13485:2016, ISO 9001:2015).
• Proficiency in quality improvement tools and techniques.
• Fluent user of standard business tools (Outlook, Word, PowerPoint, Excel, Visio).

Working Conditions

• On‑site office and manufacturing environment.

Employment Requirements

Must be authorized to work in the United States.

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.

Compensation And Total Rewards Package

The salary range for this position is outlined 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, 401(k) plans, and time‑off programs. Eligible employees may participate in an annual bonus program which depends on various factors, including individual and organizational performance.