VP of Quality

About the Role

The role will be responsible for owning the company's ISO 13485 certification roadmap, designing and building the quality management system, and serving as the primary liaison with notified bodies and registrars throughout the certification process. The VP of Quality will also partner with engineering leadership to stand up and configure the quality management system natively within the company's PLM platform, ensuring quality processes and engineering workflows are integrated rather than siloed.

Inspiren is committed to creating a culture of quality and excellence, and the VP of Quality will be instrumental in driving this effort forward. The company's products and services are designed to improve the lives of seniors and their families, and the VP of Quality will play a critical role in ensuring that these products and services meet the highest standards of quality and safety.

What You Will Do

• Own the company's ISO 13485 certification roadmap from initial gap assessment through successful third-party audit and ongoing surveillance
• Design and build the quality management system, integrating with existing engineering tools and workflows wherever possible
• Serve as the primary liaison with notified bodies and registrars throughout the certification process and beyond
• Establish and maintain core quality management system processes, including document control, CAPA, internal audit, management review, complaint handling, and post-market surveillance
• Partner with engineering leadership to stand up and configure the quality management system natively within the company's PLM platform
• Define how design controls, change management, document control, and risk management artifacts are structured, owned, and maintained inside the PLM environment
• Drive alignment between quality and engineering on data ownership, workflow approvals, and record integrity to support both day-to-day development and audit readiness
• Evaluate and continuously improve PLM-based quality management system workflows as the product portfolio and team scale
• Define quality plans, inspection criteria, and verification and validation strategies for electromechanical and software-embedded products
• Integrate quality activities into the product development process without slowing it down

What We Are Looking For

• 10+ years of experience in quality management, preferably in the healthcare technology or medical device industry
• Proven track record of leading high-performing teams and driving process improvements
• Strong understanding of quality management principles, regulatory requirements, and industry standards
• Experience with ISO 13485 certification and quality management systems
• Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams
• Strong problem-solving and analytical skills, with the ability to drive root cause analysis and corrective action
• Experience with PLM platforms and quality management system software
• Strong leadership and coaching skills, with the ability to mentor and develop team members

Nice to Have

• Experience with design controls, change management, and risk management
• Knowledge of software quality processes and IEC 62304
• Experience with supplier quality and manufacturing quality programs
• Certification in quality management, such as CQM or CQE

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a pioneering company in the senior living solutions industry
• Collaborative and dynamic work environment
• Professional development and growth opportunities
• Flexible working hours and remote work options
• Access to cutting-edge technology and tools
• Recognition and reward for outstanding performance

• Tip: Highlight your experience with quality management systems and ISO 13485 certification in your application and during interviews.
• Tip: Be prepared to provide specific examples of how you have driven process improvements and led high-performing teams in previous roles.
• Tip: Show a strong understanding of regulatory requirements and industry standards, and be prepared to discuss how you have navigated complex regulatory environments in the past.
• Tip: Emphasize your ability to collaborate with cross-functional teams and drive alignment between quality and engineering.
• Tip: Prepare to discuss your experience with PLM platforms and quality management system software, and be ready to provide examples of how you have used these tools to drive quality management efforts.
• Tip: Be prepared to discuss your approach to root cause analysis and corrective action, and provide examples of how you have driven these efforts in previous roles.
• Tip: Show enthusiasm for the company's mission and values, and be prepared to discuss how you can contribute to creating a culture of quality and excellence.