Quality Engineer III

Responsibilities

• Demonstrates high level of proficiency in applying various tools and methods to identify and realize new products or process introductions (ex. QMS, product related), and business improvements.
• Leads and contributes to the application of, and/or develops innovative applications for various risk management and risk mitigation tools and practices.
• Leads and/or contributes to root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
• Leads, conducts and supports the development of test methods in equipment, process, and product qualifications/validations.
• Develops, implements, and/or maintains process Quality control plans in accordance with product utilization and risk level and ensures they are followed.
• Develops, reviews, implements and/or maintains process controls using appropriate techniques and tools (ex. statistical process controls, statistical inspection sampling).
• Supports and ensures all levels of regulatory requirements per ISO 13485:2016 and FDA 21 CFR 820 are being utilized, in addition to other product regulatory requirements.
• Leads or participates in design/technical reviews as appropriate.
• Lead QE on product development, sustaining and continuous improvement projects.
• Act as a subject matter expert (SME) in at least 2 routine Quality areas.
• Partners with senior technical leaders (internal and external to the organization) to develop innovative approaches for identifying technical opportunities and quality improvements.
• Mentors and teaches others in various technical capabilities.
• Liaises with customer quality personnel to resolve issues and Customer Complaints.
• Generates process deviations, Customer Change Notices, validation protocols & reports.
• Assists with troubleshooting of production processes. Assists with production and product development processes. Leading development of metrology equipment. Developing and maintaining quality/control plans. 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 PFMEAs. Conducting Gage R&R studies. Resolving Corrective and Preventive Actions. Developing Quality Procedures and conducting training to all personnel as appropriate. Approving Nonconformance disposition. Analyzing production and validation data. Working on continual improvement and process assessment projects as assigned.
• Provides support or authors validation protocols for manufacturing and quality deliverables.
• Serves as the quality representative for Lightspeed projects, ensuring alignment with quality standards, risk mitigation, and process capability objectives.
• Support Equipment Calibration and Maintenance per applicable procedures.

Qualifications

• 2+ years of experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
• Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience in creating job-related documentation for quality purposes.
• Demonstrated technical writing and communication skills.
• Working knowledge of Statistical software and/or Minitab.
• Bachelor’s degree in Engineering or similar field. Biomedical, Mechanical, Engineering preferred.
• Strong attention to detail and satisfactory organizational skills.
• Able to self-manage project tasks.