Manager, Quality Systems

Stratasys; Minnetonka (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Employee stock purchase plan

401(k) with company match

Job summary

Stratasys Direct Manufacturing in Minnesota seeks a Manager of Quality Systems to lead the Quality Management System, ensure regulatory compliance, and drive continuous improvement across inspection, testing, and documentation.

You will oversee internal and third‑party audits, manage NCRs and CAPAs, mentor quality staff, and partner with operations to reduce cost of quality while ensuring on‑time delivery.

Qualifications

• Minimum seven years combined experience in quality control, management, and manufacturing operations.
• In-depth knowledge of quality control for manufacturing, ISO 9001 & AS9100 quality systems.
• Experience leading internal audits and supporting third-party certification audits.

Responsibilities

• Establish, implement, and maintain the QMS to ensure conformity and regulatory compliance.
• Plan, conduct, and document internal audits; oversee third-party certification audits.
• Lead NCRs and CAPAs; drive continuous improvement and risk management.
• Oversee inspections to ensure product conformity and timely delivery.

Skills

Quality management

Quality control

Manufacturing operations

ISO 9001

AS9100

GD&T

Audits

Education

High School Diploma or equivalent

Tools

MS Office

MS Windows

SPC software

Job description

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 Manager, Quality Systems at Stratasys Direct Manufacturing (SDM) leads and maintains the Quality Management System to ensure product conformity, regulatory compliance, and customer satisfaction. This role oversees quality inspection and testing, drives continuous improvement, and serves as a key quality liaison with customers, certification bodies, and internal teams to ensure strong quality performance and risk management.

What You Will Be Doing

• Ensure QMS processes are established, implemented, maintained, and effective
• Maintain compliance with AS and ISO certifications
• Plan, conduct, and document internal audits
• Coordinate and oversee third-party certification and surveillance audits
• Lead and support customer quality system audits
• Promote awareness of customer and regulatory requirements throughout the organization
• Responsible for leadership, guidance, and professional support of quality inspectors and personnel to achieve functional objectives
• Forecast and plan staffing to meet business needs
• Control departmental costs through productivity optimization, process improvements, and automation
• Develop, maintain, and update customer- and part-specific Quality Work Instructions
• Oversee, in-process, and final inspection activities to ensure product conformity and accuracy
• Report QMS performance, trends, and improvement opportunities to top management
• Enforce company quality standards focused on compliance, accuracy, and on-time delivery
• Drive customer satisfaction initiatives
• Collaborate with Fulfillment Services to manage customer corrective action requests
• Monitor and improve delivery performance and product conformity
• Manage Nonconformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs), ensuring timely closure and effectiveness verification
• Drive cost-of-quality reduction initiatives
• Research and implement quality tools, methodologies, and process improvements.
• Assess operational and quality risks and implement practical solutions
• Partner with Operations to enhance quality, efficiency, and customer satisfaction
• Perform contract, blueprint, and drawing reviews
• Provide inspection lead-time estimates and technical input during quoting and planning.
• Develop and deliver training for Quality personnel on procedures, equipment, and inspection methods
• Partner with Operations leadership to train employees on quality processes and best practice

As a part of Stratasys, this position requires access to information and/or technology controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR). The successful candidate must be a U.S. Citizen, lawful permanent resident of the U.S. (or, green card holder), a protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Must Have For This Role

• High School Diploma or equivalent
• Minimum seven years combined experience in quality control, management, and manufacturing operations
• In depth knowledge of quality control for manufacturing, ISO 9001 & AS9100 quality systems
• Experience leading internal audits and supporting third-party certification audits
• Demonstrated experience managing NCRs and CAPAs
• Ability to interpret contracts, technical drawings, and specification using GD&T
• Experience supervising or leading quality or inspection personnel
• Computer proficiency with MS Windows, MS Office and SPC software
• Excellent written & verbal skills including the ability to read and write specifications & procedures

Nice To Have

• Knowledge of ISO 13485
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certification
• Experience in aerospace, defense, or other highly regulated industries
• Experience serving as a Management Representative or primary QMS owner
• Lean Six Sigma Green Belt or Black Belt certification

Travel required: 10%, domestic travel

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

Additional Information

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. 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.