Manager, Quality Systems

stratasys•Minnetonka, MN

10d

About The Position

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.

Requirements

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.
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 Haves

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

Responsibilities

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