VP, Quality and Regulatory Affairs Leader

4 weeks ago

Eden Prairie, Minnesota, United States Stratasys Full time

Stratasys is a world leader in 3D printing and additive manufacturing. As a key player in the industry, we are seeking a highly skilled and experienced professional to lead our quality and regulatory affairs functions.

About the Role:

Quality:

  • Develop and implement a comprehensive quality strategy that aligns with the company's goals and objectives.
  • Oversee the development, implementation, and maintenance of the company's Quality Management System (QMS).
  • 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.

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.
  • Create a system to track new and upcoming regulations.

Leadership:

  • Build, mentor, and lead a high-performing global quality and regulatory affairs team.
  • Serve as the primary point of contact for regulatory agencies, customers, and internal stakeholders on all quality and regulatory matters.

Requirements:

  • 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 teams, including 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.

Preferred Qualifications:

  • 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.

Travel Required: 25%

About Stratasys:

  • Company Overview: Stratasys is a world leader in 3D printing and additive manufacturing.
  • Our Culture and Values: We value innovation, collaboration, and customer satisfaction.
  • Our Sustainability: We strive to reduce our environmental impact and promote sustainable practices.
  • Our Locations: We have offices and facilities around the world.

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