Quality Engineer II

Responsibilities

• Monitoring and disseminating customer quality alerts and process deviations as required.
• Generating process deviations, Customer Change Notices, validation protocols & reports.
• Leading 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 & Regression CPK, PPK & CP Control Charts SPC Gage R&R Design of Experiments.
• Working on continual improvement and process assessment projects as assigned.
• Author protocols or provides support in performing qualification validation protocols in support of design control deliverables.
• As a lead Quality Engineer on development projects, directly contribute and/or provide guidance to others to establish appropriate Design History File / Device Master Record documentation and provide detailed planning for product builds.
• Support Equipment Calibration and Maintenance per the applicable procedures.

Requirements

• Minimum 5 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 communicates with them to ensure an ongoing two-way exchange of information.
• Auditing and qualification of new suppliers may be required.
• Experience with databases and Business Intelligence (PowerBi, Tableau, etc).

Preferred Qualifications

• CQE and/or Six Sigma Green or Black belt.
• Bachelor’s degree; Physics, Optics, Mechanical, Chemical, Plastics, Engineering preferred.
• Strong attention to detail and satisfactory organizational skills.
• Able to self-manage project task.

Physical Demands

Light office work only; position may include up to 10% domestic and international travel.