Quality Engineer – Medical Device Manufacturing

Envista Holdings Corporation; Yorba Linda (CA); On-site; USD 96,000 - 117,000; Full time

Job summary

Envista Holdings Corporation in Yorba Linda, CA is seeking a Quality Engineer to assure the quality of processes and products through audits, inspections, tests, defect analysis, trend analysis, and calibration maintenance.

The role includes validating supplier and production processes, providing measurement analysis documentation, and helping departments interpret data. It supports diverse rotations and a flexible working environment.

Qualifications

• Bachelor’s degree from a four-year College or University in an Engineering discipline.
• 4-6 years of experience with FDA and international medical device regulations (i.e., 21 CFR Part 820, ISO 13485, MDD, JPAL and CMDR).
• Ability to multi-task to address existing and potential QA issues routinely.
• Proficient in Microsoft Word, Excel, Power Point, etc. or equivalent applications.

Responsibilities

• Perform audits, inspections, tests, defect analysis, and trend analysis.
• Program and troubleshoot inspection equipment; calibrate and maintain measurement systems.
• Provide documentation from measurement analysis and help departments interpret data.
• Ensure supplier and production quality via process validation and reporting results.

Skills

Auditing

Inspection

QA testing

Trend analysis

Data analysis

Calibration

Documentation

Education

Bachelor’s degree in Engineering

Tools

Microsoft Word

Excel

PowerPoint

Job description

Envista Holdings Corporation in Yorba Linda, CA is seeking a Quality Engineer to assure the quality of processes and products through audits, inspections, tests, defect analysis, trend analysis, and calibration maintenance.

The role includes validating supplier and production processes, providing measurement analysis documentation, and helping departments interpret data. It supports diverse rotations and a flexible working environment.