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Stratasys VP, Quality and Regulatory Affairs in Eden Prairie, Minnesota

VP, Quality and Regulatory Affairs

Country/Region: US

State: MN

City: Eden Prairie

Job ID: 31822

Category: Manufacturing & Operations

Make it first; make it better.

Stratasys is the world’s leading 3D printing company revolutionizing the way things are made, every day. By providing access to more complex, more flexible, more advanced solutions, our technology is transforming how ambitious businesses think and create. We make things happen for them. We make the impossible possible for our customers worldwide. And we also make careers. We can transform your dreams into reality.

As part of our ongoing commitment to continuous improvement in quality and in support of a new business structure, we are hiring a Global Vice President of Quality and Regulatory Affairs situated in our Eden Prairie, MN offices. In this role, you will be responsible for the direction, implementation, and management of regulatory affairs and quality programs across the enterprise. You will be responsible for all Quality programs in the company from raw goods to customer site. You will provide regulatory compliance oversite, establish policies and operational practices, controls to ensure compliance with applicable laws and regulations.

Essential Responsibilities

Quality – As the market leader in our industry, Quality is critical. You will help ensure we continually elevate the Quality mindset and culture for the entire product lifecycle. You will own and define, specify, and maintain the standards for quality programs and documentation to assure compliance for inspecting, testing, and evaluating the precision accuracy and reliability of all company products and services. Develop and ensure implementation and all aspects of Quality Management Systems are maintained across all regions. Lead the quality review board for Stratasys. Partner with Business Units to lead quality reviews on process excellence. Drive a culture of Quality across Stratasys. Approve customer quality agreements and ensures compliance to customer audits.

Regulatory Affairs – Responsible for providing overall leadership to ensure the development and execution of regulatory strategies and plans to enable efficient global development of products in the portfolio. Will manage the team accountable for effective regulatory submissions and communications/meetings globally, as well as developing the in-house and contracted infrastructure and capability to maintain compliance with all regulatory requirements applicable to the company’s programs. Additionally, will lead strategic initiatives within the regulatory affairs organizations and continue to build or optimize capability across all relevant regulatory subdisciplines including regulatory in medical and aerospace to achieve business results.

Management - Develop best in class management team and quality department including policies and programs in alignment with Stratasys strategy. You will be responsible for operations analysis of the department to include financial processes, budgeting, and corporate allocations process. Complete annual performance process with regular feedback on individual and team performance. Responsible to drive and maintain high engagement of the organization through programs and communication.

Our ideal candidate will have Knowledge of principals and processes involved in business and organizational planning and budgeting with exceptional skills in analysis and decision making. You will have been successful in creating a quality culture in a global company. You will be comfortable handling multiple competing priories in a fast-paced environment and have experience working within a high-growth, global technology company, and have a real passion for excellence.

This role will require international travel

Basic Qualifications:

  • Degree in Engineering or Quality Management

  • Minimum of 10 years in Quality Leadership role, 5 of which in a global role

  • 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

  • Experience working across all functions in the product lifecycle

  • Experience leading Regulatory processes in either the Medical, Aerospace or Automotive

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

  • Leading through business transformation

  • Knowledge of 3-D printing or additive manufacturing environments