|Job Type:||Full Time|
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
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. You will interact with customers, cohorts, and suppliers. This site doesn't silo its employees, and you'll gain a wide variety of experience in this role that you can leverage move up within the TE Connectivity organization.
- 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.
- Minimum 5 years working experience in ISO13485 and 21CFR (QSR) environment
- Exposure to EU MDD regulatory environment
- Understanding of EU MDR regulatory requirements
- Be able to write excellent technical documents
- Exposure to Sterilization process (EO/Gamma) for medical devices
- Person need to be able to multi task efficiently
- Exposure to 8D methodology of problem solving or other problem solving techniques such as SPS (Statistical Problem Solving)
- Flexible to work long hours as contract manufacturer is located in China
About TE Connectivity
TE Connectivity is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.
What TE Connectivity offers:
We offer competitive total rewards compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive and will meet the needs of our associates.
- Generous 401(k) Plan
- Tuition Reimbursement
- Benefits start on day one
- Charity Donation Matching Program
- Competitive Paid Time Off
- Employee Resource Groups
- Employee Stock Purchase Program
- Healthcare for Associates and Families
- Health and Wellness Incentives
- Life Insurance and Disability Protection
Throughout our Global reach and various Business Units, we take a balanced approach to the benefits we provide. Many benefits are company-paid, while others are available through associate contribution. Specific benefit offerings can vary by location.