SUMMARY

Under minimal supervision from the Quality Manager, the Senior Quality Engineer will support Engineering and Quality Assurance activities and assist Quality Control and Regulatory as part of a comprehensive Quality Management System.

QUALIFICATIONS

• Excellent communication skills and the ability to work with people at all levels.
• Ability to work independently and in a team environment.
• Strong organization skills, attention to detail, self-motivator, ability to multi-task and meet timelines.
• Working knowledge of desktop computer office software and e-mail is required.
• Understand calibration fundamentals.
• Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges, and pin gauges.
  
  
  
• Optical comparator.experience preferred.

• Experience with Keyence Vision Systems is required.

• Experience in SOLIDWORKS or 3D modeling is required.

• Knowledge and understanding of Medical Device Regulations / Certifications such as 21CFR820 & ISO13485:2016.

• **Medical Device experience is required.
  
  EDUCATION and EXPERIENCE

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Read, understand, and interpret engineering drawings and associated GD&T.
• Perform transactions in ERP system, as necessary.
• Identify non-conforming product and generate non-conformance reports as needed.
• Read and conform to all company policies and procedures.
• Interact and communicate with internal departments, including Purchasing, Shipping / Receiving, Engineering, Customer Service, and Sales / Marketing .
• Authority to place product on hold.
• Involved with new product development (NPD) process and the support of existing and previously commercialized products.
• Review and approve engineering drawings and assist in determining Critical-To-Quality Dimensions.
• Create, Review, and Approve Inspection Plans and Inspection tools as required.
• Create and Support validations for new and existing products and processes, including packaging and sterilization.
• Create and Support IQ, OQ, and PQ activities for equipment and additive implants.
• Perform and support Gage Repeatability and Reproducibility (Gage R & R) studies.
• Perform and support First Article Inspection / Inspections on Prototypes.
• Perform Statistical rationales as required.
• Support supplier quality management activities, including qualification, evaluation, and investigations.
• Support Post Market Surveillance activities.
• Support Complaint/NC/CAPA teams through the identification and development of corrective action plans, verification, and closure.
• Perform and support Design and Process FMEA activities.
• Collect, analyze, and summarize data and make recommendations as required.
• Support and prepare for site-level internal, external, supplier, and customer audits.
• Provide quality support to identify and resolve quality issues to ensure safe and effective medical devices.
• Interact and coordinate activities with other departments, support, and customers.
• Identify and implement opportunities for continuous improvement.
• Create and update Quality System Procedures and Instructions when applicable.
• Supports Quality, Engineering, and Regulatory to meet company and department objectives.
• Other duties as assigned by management.