Medical Device Quality Engineer – Validation & QMS

envista; United States; On-site; USD 85,000 - 115,000; Full time

Job summary

Envista in Madison, WI is seeking a Quality Engineer to lead validation activities, risk management, and design controls across NPD, sustaining engineering, and manufacturing. You will drive statistical methods and V&V to ensure regulatory and customer requirements are met.

The role requires onsite presence five days a week; you will collaborate with R&D, Regulatory, Operations, and Quality Systems, provide coaching to junior staff, and support internal/external audits and continuous improvement

Qualifications

• Bachelor's degree in a related engineering field.
• 2-5 years of quality experience in a regulated industry.
• Experience with validation, design controls, risk management, investigations, CAPA, statistics.
• Knowledge of FDA medical device QMS, ISO 13485, GMP requirements.

Responsibilities

• Lead process, equipment, software, and test method validation activities, including planning, protocol development, execution oversight, data analysis, deviation resolution, final reporting, and maintenance of applicable validation master plans.
• Serve as the Quality Engineering representative for new product development, sustaining engineering, verification and validation, risk management, and design or process changes, including review and approval of 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, Gauge R&R, SPC, FMEA, capability analysis, sampling plans, and trend analysis, to assess risk and improve products, processes, inspection methods, and control strategies.
• Lead technical supplier quality support for qualification, audits, validations, change assessments, and evaluation of supplier corrective action responses, while routine SCAR administration and supplier monitoring remain within Quality Systems.
• 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.
• Partner with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems to ensure quality requirements are appropriately incorporated and maintained 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.

Skills

Statistical analysis

Technical writing

Cross-functional communication

Project leadership

Education

Bachelor's degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering

Tools

MasterControl

Oracle ERP

Microsoft Office

Job description

Envista in Madison, WI is seeking a Quality Engineer to lead validation activities, risk management, and design controls across NPD, sustaining engineering, and manufacturing. You will drive statistical methods and V&V to ensure regulatory and customer requirements are met.

The role requires onsite presence five days a week; you will collaborate with R&D, Regulatory, Operations, and Quality Systems, provide coaching to junior staff, and support internal/external audits and continuous improvement