VP, Quality & Regulatory Affairs

Stratasys is a world leader in 3D printing!

 

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

 

As the VP, Quality & Regulatory Affairs, you will lead all aspects of quality assurance and regulatory compliance across the Global Enterprise. You will ensure that our products and processes meet or exceed industry standards, regulatory requirements, and customer expectations. This position requires a deep understanding of global regulatory frameworks, as well as experience in navigating complex quality systems within the 3D printing or advanced manufacturing sectors. As well as experience interacting with key customers, specifically in the medical device sector.

 

What you will be doing:

 

Quality:

• Develop and implement a comprehensive quality strategy that aligns with the company’s goals and objectives. Drive continuous improvement initiatives to enhance product quality, reliability, and safety.
• Oversee the development, implementation, and maintenance of the company’s Quality Management System (QMS). Ensure all processes, from product design to manufacturing, meet established quality standards.
• Identify potential quality risks and develop mitigation strategies. Lead internal and external audits, manage non-conformances, and ensure effective corrective and preventive actions (CAPA).
• Work closely with R&D, supply chain, regions and other departments to ensure quality requirements are integrated into product development and production processes.
• Ensure that suppliers meet quality standards and contribute positively to the overall supply chain.

 

Regulatory Affairs:

• Develop and implement a comprehensive regulatory strategy that aligns with the company’s goals and objectives.
• Ensure compliance with all relevant international, federal, and state regulations, including ISO, FDA, CE Marking, and other applicable standards. Lead the preparation and submission of regulatory filings, product registrations, and other required documentation.
• Create a system to track new and upcoming regulations which includes developing and executing the implementation of the regulations.

 

 

Leadership:

• Build, mentor, and lead a high-performing global quality and regulatory affairs team. Foster a culture of accountability, continuous improvement, and excellence.
• Serve as the primary point of contact for regulatory agencies, customers, and internal stakeholders on all quality and regulatory matters. Provide regular updates to the executive team on compliance status, quality metrics, and risk management activities.

 

Other

• Follow all company safety policies and procedures
• Attend all required company training
• Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values.
• Other Responsibilities as assigned by the department or manager

 

 

Must have for this role

 

• 10+ years of experience in quality assurance and regulatory affairs, with a significant portion in medical device, or advanced manufacturing industries.
• Proven track record of successfully leading quality and regulatory functions in a global environment.
• Experience leading global quality tea