Nobel Biocare Quality Engineer (On-Site Yorba Linda, CA)

About the role

The Quality Engineer assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. He/She assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data.

Responsibilities

• Perform audits, inspections, and tests to ensure product and process quality
• Conduct defect analysis and trend analysis
• Program and troubleshoot inspection equipment
• Perform calibration maintenance
• Report on results of measurement standards
• Validate processes to ensure consistent quality of suppliers and production
• Provide documentation from measurement analysis
• Help departments interpret collected data

Requirements

• 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 (e.g., 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, PowerPoint, or equivalent applications

Preferred Qualifications

• Compliance certifications (e.g., ISO 13485, ISO 14791), Six Sigma Greenbelt: Process Excellence
• Availability to work different rotations or hours depending on business demands
• Flexibility to work in a flexible working environment
• Strong communication and collaboration skills; ability to work individually or across various functional teams
• Willingness to travel domestically or internationally depending on business needs
• Ability to analyze trend data on quality systems metrics using standard statistical techniques such as Minitab
• Effective project management skills

Benefits

• Medical, dental, and vision benefits
• 401(k) match
• Annual performance bonus

Pay

$95,600 – $116,900

This position is located on-site in the Yorba Linda, CA office, 5 days per week.