Quality Systems Lead

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.
 
The Quality Systems Lead will manage and enhance our Quality Management System (QMS), ensuring compliance with regulatory standards and customer expectations. This role is responsible for executing quality initiatives, promoting best practices, and driving continuous improvement across the organization. The ideal candidate will collaborate with global cross-functional teams, develop and communicate strategic plans for quality advancement, and may lead a small team of direct reports. Strong leadership, project execution, and communication skills are essential to succeed in this role.

What you will be doing:
•    Develop, implement, and maintain global Quality Management Systems (QMS) processes to ensure compliance with industry standards, regulatory and customer requirements
•    Lead and execute projects focused on quality, compliance, and process improvements
•    Conduct regular audits and assessments to identify areas for improvement and ensure adherence to QMS
•    Ensure QMS reflects actual activities, business needs and supports New Product Introduction (NPI) requirements
•    Monitor and report on key quality metrics and performance indicators
•    Assist in the preparation and submission of quality documentation to support regulatory or customer initiatives
•    Stay current on all Stratasys existing certified standards and regulations and new and evolving standards for the industry
•    Assist in the review of customer contracts
•    Drive the transition from process improvement to implementation, ensuring long-term sustainability of changes
•    Analyze and optimize processes, procedures, and compliance improvements in collaboration with cross-functional teams globally
•    Foster a culture of quality by coordinating and overseeing the implementation of continuous improvement standards, including training, opportunity identification, and improvement development
•    Ensure best practices are followed and drive continuous improvement initiatives
•    Performing proficiency assessment of current process vs. benchmarks for end use manufacturing to help establish a proficiency improvement plan
•    Provide training and support to staff on QMS processes and procedures
•    Provide work direction to direct team, communicate company expectation metrics and Key Performance Indicators (KPIs), and manage performance and improvement activities
•    Manage, develop, and coach a small team of Quality professionals
•    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:
•    Bachelor’s degree in Industrial Engineering, Quality Management or another related field
•    Proven experience in quality management systems and process improvement
•    Strong knowledge of industry standards and regulatory requirements (e.g., ISO 9001, ISO13485, AS9100, 21CFR Part 820, Medical Device Regulation, Six Sigma)
•    Experience in project and/or organizational change management (OCM)
•    Ability to work effectively in a global, cross-functional team environment

Nice to have:
•    Lean Six Sigma Certification 

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

At Stratasys we have designed a comprehensive Total Rewards program that goes beyond the basics and supports our People First strategy. When you join Stratasys, you’ll gain access to benefits and perks that will support you and your family both inside and outside of work. 

For this position, the typical annual starting base salary is from $114,277 to $134,226, which does not include variable incentive pay. This range represents a good faith estimate for this position. Your individual base pay will depend on your skills, qualifications, geographical location, and/or experiences.

In addition to a competitive salary, we offer a comprehensive total rewards package (e.g., Medical, Dental & Vision, Health Savings Accounts, Mental Health Resources etc.), recognition programs, employee stock purchase plan, and 401(k) with company match. 

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.