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Quality & Reliability Engineer- Medical


At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

The  Quality Engineer investigates the root cause and follows through on effective corrective actions to prevent reoccurrence for the customer and internal quality issues. This person will establish inspection standards, plans, frequencies and test methods as well as establish and maintain FMEA’s. Responsibilities include: 

  • Preparing and updating Operations procedures and associated documentation.Reporting area of responsibility metrics.
  • Supporting customer and surveillance accreditation audits.
  • The Senior Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Quality review of responsible area validation documentation.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Will assist in issues related to Metrology, Inspection, Testing, Product stability, and vendor certification programs.
  • Will lead and manage the Material Board to ensure products are appropriately dispositioned within time requirements.
  • Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.
  • Will assist and train associates in concepts of probability and statistics.
  • Design and develop forms and instructions for recording, evaluating, and reporting quality data.
  • Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.
  • Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.
  • Perform Supplier Quality Audits as necessary.
  • Assist with the development and maintenance of the company-wide validation programs.
  • Reports verbally and in writing to the Director / Manager regarding the progress and results of projects.
  • Participates with the Director / Manager in the preparation of divisional, departmental, and project goals.
  • Assists the Director / Manager in presentations of technical nature when requested.
  • Ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001/ISO13485/MDD Standards.

What your background should look like:

  • Min. 1-3 years' experience as quality engineer in a similar position and industry
  • 1+ years of quality experience in component and device manufacturing
  • 1+ years experience with Medical Devices 
  • ASQ Certified Quality Engineer preferred
  • Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
  • Six Sigma Green/Black belt preferred 
  • BS/BA degree with a scientific emphasis required

Competencies

Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity
TE Connectivity is a 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 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.

Location: 

PLYMOUTH, MN, US, 55442

City:  PLYMOUTH
State:  MN
Country/Region:  US
Travel:  None
Requisition ID:  67131
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Manufacturing Engineer, Engineer, Developer, Engineering, Quality, Technology

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