Quality Engineer III

• ◆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).
• ◆Support and ensure all levels of regulatory

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.
• ✓Interprets and implements standard and non-standard sampling plans.
• ✓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.
• ✓Liaising with customer quality personnel to resolve issues and Customer Complaints.
• ✓Generating process deviations, Customer Change Notices, validation protocols & reports.
• ✓Assisting with troubleshooting of production processes
• ✓Assisting 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.

• ✓Ability to create job-related documentation for quality purposes.
• ✓Familiarity with ISO 13485 standards and FDA 21 CFR 820 regulations.
• ✓Minimum 2 years’ experience in a Quality Engineering role for a medical device manufacturer and/or start-up company, or equivalent engineering experience.
• ✓Demonstrated technical writing and communication skills.
• ✓Working knowledge of Statistical software and/or Minitab.
• ✓Bachelor’s degree or equivalent experience.

Interact with customer and supplier companies in a professional manner; proactively communicate with them to ensure an ongoing two-way exchange of information. Auditing and qualification of new suppliers may be required.

• ✓CQE and/or Six Sigma Green or Black belt
• ✓BS degree: Biomedical, Mechanical, Engineering preferred
• ✓Strong attention to detail and satisfactory organizational skills
• ✓Able to self-manage project tasks