Quality Systems Specialist

Principal Quality Systems Specialist Are you passionate about building and improving quality systems that support innovative medical technologies? We're seeking a Principal Quality Systems Specialist to play a key leadership role in driving quality system excellence across our organization. In this highly visible position, you'll partner with cross-functional teams to strengthen compliance, improve quality processes, lead inspection readiness activities, and ensure alignment with global regulatory requirements.

This is an exciting opportunity for an experienced quality professional who enjoys influencing strategy, solving complex compliance challenges, and helping deliver high-quality products that make a meaningful impact on patients' lives. What You'll Do As a Principal Quality Systems Specialist, you'll help shape and maintain a robust quality management system while serving as a trusted advisor across the organization.

Lead the development, implementation, and continuous improvement of quality systems, programs, and procedures. Ensure compliance with FDA, EU MDR, ISO 13485, and other applicable global regulatory requirements. Serve as a subject matter expert on quality system processes and regulatory expectations. Lead audit and inspection readiness activities, including preparation, execution, response management, and remediation efforts.

Partner with business leaders to assess quality system effectiveness and drive ongoing improvements. Oversee and support critical quality processes, including: CAPA Change Control Training Management Review Issue Escalation Internal Audits External Audits Lead complex investigations and root cause analyses to identify systemic improvements. Facilitate best-practice sharing and quality system standardization across teams and locations.

Support regulatory inquiries, legal requests, inspections, and compliance initiatives. Analyze quality system metrics and identify opportunities to improve performance and effectiveness. Mentor and guide quality professionals while supporting cross-functional project teams. Represent Quality Systems as a key stakeholder for strategic initiatives and business projects. Required Qualifications Bachelor's degree in Engineering, Science, Quality, Regulatory Affairs, or a related technical discipline.

7+ years of experience in Quality Systems, Quality Engineering, Quality Assurance, Regulatory Compliance, or Medical Device Quality. Strong knowledge of FDA Quality Management System Regulation (QMSR), 21 CFR Part 820, EU MDR, and ISO 13485. Experience supporting and improving key quality system processes, including CAPA, Change Control, Training, and Audit Management. Demonstrated expertise in root cause analysis, risk management, and quality system investigations.

Experience leading internal audits, external audits, regulatory inspections, and remediation activities. Strong analytical, communication, and project management skills. Ability to influence cross-functional stakeholders and drive organizational change. Preferred Qualifications Advanced degree in a technical or scientific discipline. Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or related certification.

Experience supporting global quality systems within a multinational medical device organization. Proven success implementing quality system improvements and driving compliance initiatives. Experience leading complex CAPA programs and enterprise-level process improvements. Prior mentoring, coaching, or leadership experience. Experience supporting regulatory inspections from FDA, Notified Bodies, or other international agencies.

Don't meet every qualification? We encourage you to apply. We're interested in candidates who bring strong quality systems expertise, a passion for continuous improvement, and a desire to make an impact. Job Type & Location This is a Contract position based out of St Paul, MN. Pay and Benefits The pay range for this position is $50.00 - $78.00/hr. Individual