Senior Medical Quality Engineer

Last updated 4 days ago
Location:Medway, Massachusetts
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.

What you'll be doing...

As a Senior Quality and Reliability Engineer, you are responsible for;

  • Maintain and comply with the requirements of MDSAP, ISO 13485, GMP, 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.
  • 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.
  • 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.
  • 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.
  • 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 of customer complaint handling and investigation.
  • Click here to learn more about Life at TE

What your background should look like:

  • Minimum 5 years working experience in ISO13485 and 21CFR (QSR) environment
  • Be able to write excellent technical documents
  • 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)

Work Location

The position is located at our Medway, Massachusetts site.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity
TE Connectivity is a $12 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 approximately 80,000 employees, including more than 7,500 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more atwww.te.com and onLinkedIn, Facebook, WeChatandTwitter.

What TE Connectivity offers:

We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.

  • Competitive Salary Package
  • Performance-Based Bonus Plans
  • Health and Wellness Incentives
  • Employee Stock Purchase Program
  • Community Outreach Programs / Charity Events
  • Employee Resource Groups