Stratasys
VP, Quality & Regulatory Affairs
Stratasys, Eden Prairie, Minnesota, United States, 55344
VP, Quality & Regulatory Affairs
Location:
Eden Prairie, MN, US
Job ID: 53845
Category: Manufacturing & Operations
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 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
Travel required: 25%
What you will be part of:
Company Overview -
https://www.stratasys.com/en/about-us/history/
Our Culture and Values -
https://www.stratasys.com/en/about-us/culture/
Our Sustainability “3D Printing a Better Tomorrow”
-
https://www.stratasys.com/en/about-us/sustainability/
Our Locations
-
https://www.stratasys.com/en/contact-us/office-locations/
Check out our Video -
https://www.youtube.com/watch?v=6wmDfmt2bNI
To perform this job successfully
, 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.
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. Please view Equal Employment Opportunity Posters provided by OFCCP here (http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .
Location:
Eden Prairie, MN, US
Job ID: 53845
Category: Manufacturing & Operations
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 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
Travel required: 25%
What you will be part of:
Company Overview -
https://www.stratasys.com/en/about-us/history/
Our Culture and Values -
https://www.stratasys.com/en/about-us/culture/
Our Sustainability “3D Printing a Better Tomorrow”
-
https://www.stratasys.com/en/about-us/sustainability/
Our Locations
-
https://www.stratasys.com/en/contact-us/office-locations/
Check out our Video -
https://www.youtube.com/watch?v=6wmDfmt2bNI
To perform this job successfully
, 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.
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. Please view Equal Employment Opportunity Posters provided by OFCCP here (http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) .