Quality Engineer II

Overview

The Quality Engineer provides customer and factory facing quality support. The position includes managing the interface between Resonetics, its customers and suppliers quality organization, assisting with transition and sustaining of laser manufacturing processes, and support for our quality management system. The Quality Engineer position uses Quality Engineering techniques including : Problem solving using Lean Six Sigma methodology, Process Validations and Verifications, Process Development and optimization, Gage R&R, and reducing dependence on inspection along with ISO 13485 and / or 21CFR820 compliance.

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

Responsibilities

• Monitoring and disseminating customer quality alerts and process deviations as required.
• Generating process deviations, Customer Change Notices, validation protocols & reports.
• Lead troubleshooting Quality opportunities during product launches and assisting with the Product Development Process.
• Leading development of metrology equipment
• Developing and maintaining quality / control plans and PFMEA.
• Ensuring Quality Management Systems procedures and appropriate regulations and industry standards are being utilized throughout the product development and process development processes.
• Developing Risk documentation in compliance with the QMS and regulatory standards, such as PFMECAs.
• Conducting Gage R&R studies and Design of Experiments
• Developing Quality Procedures and conducting training to all personnel as appropriate
• Approving Nonconformance disposition
• Analyzing production and validation data with advance statistic such as

Anova & Regresion

Required Qualifications

Preferred Qualifications

Physical Demands

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000-$81,000.

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're passionate about innovation and thrive in a fast-paced environment, we'd love to hear from you.

For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.