Quality Engineer

Description

Position Summary

The Quality Engineer independently leads technical quality engineering and validation activities supporting new product development, sustaining engineering, manufacturing, and quality system compliance. The role serves as a Quality representative 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.

Essential Duties and Responsibilities

Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software.

Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement.

Ensure validation activities comply with regulatory requirements and organizational/industry standards.

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, 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.

Incidental Duties: The above statements describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned by management, as required.

Job Requirements:

Requirements

• Education and Experience
• 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, preferably in medical devices.
• Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
• Quality Engineer certification or another relevant professional certification preferred.
• Required Skills and Abilities
• Working knowledge of applicable medical device quality system requirements, ISO, GMP requirements, and relevant international standards.
• Ability to independently interpret and apply regulatory, quality system, technical, and customer requirements 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 the ability to quickly learn eQMS, ERP, and other business systems; experience with MasterControl, Oracle, or comparable systems preferred.
• Ability to manage multiple priorities with minimal oversight, adapt to changing business needs, communicate effectively in English, and travel as required.
• Physical Demands
• Employee is required to sit at a desk for extended periods and frequently use hands and fingers.
• Position requires occasional standing, walking, reaching, bending, and stooping.
• The work environment has a moderate noise level. Safety glasses are required in production areas or as otherwise indicated.
• LI-RJ1
• IND123
• Target Market Salary Range:
• Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
• For Field Sales roles, the salary range listed reflects base pay only and does not include incentive pay opportunities under the applicable sales compensation plan
• $79,200 - $96,800
• Operating Company:
• Orascoptic