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. 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 compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in St Paul,MN. Application Deadline This position is anticipated to close on Sep 23, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr