The Senior Quality Engineer will work cross-functionally with the manufacturing engineering teams and the NPI teams on a variety of initiatives related to TE's medical sensors.
Maintain and comply with the requirements of MDSAP, ISO 13485, GMP, FDA 21 CFR Part 820 and other applicable regulations.
Implement and develop quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).
Support in developing and execution of Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.
Ensure that required specifications are implemented for incoming/ in-process/ outgoing quality inspections.
Support in developing and maintaining the dFMEA/pFMEA/ uFMEA process for finished good medical devices working in a cross-functional group. 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.
Participates in Material Review Board activities, including manufacturing facilities ensuring proper trending, closure of issues and dispositions are appropriately justified.
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.
Review and approve specifications (input/outputs), verification and validation, risk management activities, and Quality Plans.
Conduct Quality Engineering studies relating to product and process development or corrective actions including Design of Experiments, Test Method Validations, Gage R&R, Cpk, SPC and process validations.
Working knowledge of concepts of probability and statistic.
Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.
Establishing inspection standards, plans, frequencies and test methods.
Support Production on all quality-related activities, including working closely with Engineering and other applicable functions.
Support of customer complaint handling and investigation.
Support TE sensors Temperature production site in China (Optical and Medical).
BS/BA degree with a scientific/engineering emphasis required
Senior Quality Engineer Experience
3-8 years' of experience in a regulated medical device environment (contract manufacturing or OEM)
Excellent communication and interpersonal skills, proven problem-solving capability
Six Sigma Green/Black belt preferred
ASQ Certified Quality Engineer or MS degree desirable
Catheter experiences desirable
Auditor Certification as a Lead ISO auditor 13485 certification preferred
This position requires access to information which is subject to stringent controls under the International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). Applicants must be a U.S. citizen or national, U.S. lawful permanent resident, person granted asylee status in the U.S., or person admitted into the U.S. as a refugee.
Internal Number: 31414
About TE Connectivity
TE Connectivity Ltd., is a $13 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 78,000 employees, including more than 7,000 engineers, working alongside customers in nearly 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.