VP, Quality Assurance

2 weeks ago

Eden Prairie, Minnesota, United States Stratasys Full time
Job Title: VP, Quality

Stratasys is a world leader in 3D printing, driving innovation and excellence in additive manufacturing. We are seeking a highly skilled and experienced VP, Quality to lead our quality assurance and regulatory compliance efforts across the global enterprise.

Key Responsibilities:
  • 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.

Stratasys is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their protected Veteran or disabled status and will not be discriminated against for their race, color, religion, sex, age, disability, military status, or national origin or any other characteristic protected under federal, state, or applicable local law.

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