Senior Manager, QS Change Management
hims & hers
PMP
Senior Quality Systems Manager
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • California, Colorado, Massachusetts
Visit company websiteSalary
💰 $149,600 - $224,400 per year
Job Level
Senior
Tech Stack
PMP
About the role
- Drive the evolution of Medtronic’s product development processes and serve as a domain expert in Design Control
- Lead and coach internal customers across a diverse product portfolio to elevate Design Control capabilities
- Proactively identify and implement large-scale initiatives to enhance rigor, productivity and user experience leveraging cutting-edge technologies and methodologies
- Lead enterprise-wide initiatives with emphasis on Design, Reliability & Manufacturability (DRM) to ensure product quality, regulatory compliance and operational excellence across Medtronic Operating Units
- Apply Design for Reliability and Design for Manufacturability principles to reduce risk, improve First Time Quality (FTQ), and enable efficient design transfer
- Guide cross-functional teams through the Product Development Process (PDP) with strong focus on positive design control outcomes and regulatory adherence
- Serve as a subject matter expert in CAPA and Post-Market Surveillance (PMS), ensuring field performance insights are incorporated into early design phases
- Apply systems engineering principles to coordinate complex, multi-disciplinary product development efforts from concept through commercialization
- Leverage biomedical engineering knowledge to ensure designs meet functional, safety, and efficacy requirements in compliance with medical device standards
- Maintain deep familiarity with FDA 21 CFR Part 820, ISO 13485, and other design-controlled regulations, providing expert guidance on compliance throughout the development lifecycle
- Partner closely with R&D and Quality colleagues to embed best practices in technical rigor, simplify execution, and strengthen decision-making and solution design
- On-site role requiring work in Mounds View, MN; Lafayette, CO; Boston, MA; Memphis, TN; or Santa Rosa, CA offices 4-days per week minimum
Requirements
- Bachelor’s Degree with 7+ years of work experience in Quality, with 5+ years of managerial experience OR Advanced Degree with 5+ years of work experience in Quality with 5+ years of managerial experience
- Experience leading complex projects/programs (preferred)
- Experience with SPC, CAPA, NCMR, PDP processes (preferred)
- Effective planning and organization skills including ability to work against multiple objectives simultaneously (preferred)
- Ability to establish and maintain a trusted role with various stakeholders across the organization (preferred)
- PMP Certification (preferred)
- Working knowledge of Quality System Regulations such as QSR 21 CFR 820 and ISO 13485:2016 (preferred)
- Manufacturing Experience (preferred)
- Green Belt Six Sigma/DRM Training/Certification (preferred)
- Effective verbal and written communication, analytical, influencing and interpersonal skills (preferred)
- Demonstrated working knowledge of process validation, statistical methods, risk management (preferred)
