Stratasys VP Quality & Regulatory Affairs 

United States, Minnesota, Eden Prairie 

518639064

As theVP, Quality & Regulatory Affairs,you will leadall 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.

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 team to include strategy execution, business operations, operational efficiencies, and other related to quality or regulatory affairs on a global level in a capital equipment manufacturer
• Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
• Experience working across all functions in the product lifecycle
• Experience leading Regulatory processes in either the Medical, Aerospace or Automotive

Nice to Have

• Experience with budgeting and leadership of a multi-functional team
• 4+ years of work experience working with senior-level executives in a matrixed organization
• Lean Six Sigma Leader
• Project Management Certification
• Leading through business transformation
• Knowledge of 3-D printing or additive manufacturing environments

What​ ​you​ ​will​ ​be​ ​part​ ​of:

• Company Overview -
• Our Culture and Values -
• Our Sustainability “3D Printing a Better Tomorrow”-
• Our Locations-
• Check out our Video -

, an individual must be able to perform each essential duty satisfactorily. Stratasys will provide reasonable accommodations for qualified individuals with disabilities. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.