Senior Quality Engineer

Job Overview

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

JOB OVERVIEW
Position is responsible for direct interaction and support and customer quality management, assuring that QSRs and QMS are in accordance with regulatory standards and promote continuous improvement of the Quality System. Other duties may be assigned on an individual basis: This position will report to the Director/Quality Assurance. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
  
• Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
  
• Develop and maintain the PFMEA process for manufacturing.
  
• Support/participate in regulatory agency and customer quality audits.
  
• Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.
  
• Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.
  
• Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.
  
• Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.
  
• Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
  
• Provides problem solving support, clarification of process performance requirements, to successfully complete assigned tasks as directed.
  
• Manage project transfers related activities
  
• Works with other Quality Engineers to ensure that
  

o Quality Problems are detected and corrected in the earliest stages of production
o Quality Problems are not transferred to our customer

What your background should look like:

• BS/BA degree with a scientific/engineering emphasis required.
  
• AQS Certified Quality Engineer or MS degree desirable
  
• Six Sigma Green/Black belt recommended
  
• Minimum of 5 years’ experience in a related regulated medical device environment. Catheter/MI experiences an advantage.
  

Competencies