Lead Quality Engineer – Medical Devices & Process Excellence

Resonetics; San Diego (CA); On-site; USD 70,304 - 102,000; Full time

Job summary

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, is seeking a Quality Engineer to support customer and factory quality interfaces and streamline laser manufacturing transitions. You’ll apply Lean Six Sigma, process validations, PFMEA, and ISO 13485/21 CFR 820 standards while collaborating with customers and suppliers.

You will drive quality improvements across development and production, contribute to design history files, and mentor

Qualifications

• Minimum 5 years in a Quality Engineering role for medical devices.
• Demonstrated technical writing and communication skills.
• Working knowledge of statistical software (Minitab).
• Experience with databases/BI tools (PowerBI, Tableau).

Responsibilities

• Monitor and disseminate customer quality alerts and process deviations.
• Generate process deviations, China Notices, validation protocols & reports.
• Lead troubleshooting during product launches and assist product development.
• Lead development of metrology equipment and PFMEA.
• Develop and maintain quality/control plans and QMS procedures.
• Ensure QMS/regulatory standards are applied in development and process.
• Develop risk documentation per QMS and regulatory standards.
• Conduct Gage R&R studies and DOE.
• Develop quality procedures and train personnel as appropriate.
• Approve nonconformance disposition.
• Analyze production/validation data with advanced statistics (ANOVA, regression).
• Create/design documentation via DHF/Device Master Record planning.
• Support calibration and maintenance of equipment per procedures.

Skills

Technical writing

Communication

Statistical software

Minitab

Education

Bachelor's degree or equivalent

Tools

PowerBI/Tableau

Job description

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, is seeking a Quality Engineer to support customer and factory quality interfaces and streamline laser manufacturing transitions. You’ll apply Lean Six Sigma, process validations, PFMEA, and ISO 13485/21 CFR 820 standards while collaborating with customers and suppliers.

You will drive quality improvements across development and production, contribute to design history files, and mentor