Quality Engineer

Envista Dentistry•Madison, WI

About The Position

The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality system compliance. The role represents Quality on cross-functional teams and applies validation, design controls, risk management, statistical methods, and structured problem-solving to ensure products and processes meet applicable regulatory, quality system, and customer requirements. The position develops and executes equipment, process, and system validation protocols, including software, and prepares reports that interpret validation data and identify trends and improvement opportunities. It also provides Quality Engineering support across product development and lifecycle changes, investigations, supplier quality, audits, and continuous improvement. The role collaborates with engineering, operations, regulatory, procurement, and quality teams, and provides technical guidance to less experienced Quality Associates.

Requirements

Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering, or a closely related engineering field.
Typically 2–5 years of quality experience in a regulated industry.
Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards.
Ability to interpret and apply regulatory, quality system, technical, and customer requirements independently and resolve complex quality issues using structured problem-solving.
Proficiency in statistical analysis and data interpretation, including practical applications of DOE, FMEA, capability analysis, and sampling methods.
Strong technical writing, project leadership, organization, and cross-functional communication skills.
Ability to understand product applications, specifications, functionality, assembly, manufacturing processes, and test methods.
Microsoft Office skills and ability to learn eQMS, ERP, and other business systems.
Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
Ability to perform the essential duties satisfactorily and function effectively in a fast-paced environment where priorities may change.
Ability to sit at a desk for extended periods and frequently use hands and fingers; occasional standing, walking, reaching, bending, and stooping are required.
Safety glasses are required in production areas or as otherwise indicated.

Nice To Haves

Quality Engineer certification or another relevant professional certification.
Quality experience in the medical device industry.
Experience with MasterControl, Oracle, or comparable systems.

Responsibilities

Develop and execute IQ, OQ, and PQ validation protocols for equipment, processes, and systems, including software.
Prepare validation reports and analyze validation data to identify trends, anomalies, and improvement opportunities.
Ensure validation activities comply with regulatory requirements and organizational and industry standards.
Represent Quality Engineering on new product development, sustaining engineering, verification and validation, risk management, and design or process change activities; review and approve applicable technical documentation.
Lead or provide technical support for investigations involving nonconformances, complaints, CAPAs, and supplier or manufacturing quality issues, including root cause analysis, corrective action development, and effectiveness assessment.
Apply quality engineering and statistical tools, including DOE, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies.
Provide technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses.
Participate in regulatory, notified body, customer, corporate, and internal audits by providing technical documentation and evidence-based responses within the role’s areas of responsibility.
Collaborate with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to incorporate and maintain quality requirements throughout the product lifecycle.
Provide technical guidance to less experienced Quality Associates and support assigned departmental quality and continuous improvement initiatives.
Follow departmental Standard Operating Procedures, Work Instructions, and applicable safety requirements.
Manage multiple priorities, adapt to changing business needs, and travel as required.