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Sr Quality Engineer

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

TE’s Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world’s leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.

The senior quality engineer will focus on one of TE Medical's value streams, working with manufacturing teams to sustain and improve manufacturing quality on Class II and III medical devices. You'll utilize your statistical strengths in SPC-implementation projects, increase efficiencies using continuous improvement methods, and interact with the customers frequently

TEGTA19

Job Responsibilities

  • Investigation of root cause and following through on effective corrective actions to prevent reoccurrence for the customer and internal quality issues.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA’s.
  • 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.
  • 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.TEGTA19

What your background should look like:

  • BS/BA degree with a scientific emphasis required
  • Min. 5 years' experience as quality engineer
  • Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • ASQ Certified Quality Engineer preferred Six Sigma Green/Black belt preferred Quality experience in component and device manufacturing preferred.
  • Excellent written and oral communication skills essential.
  • Relocation is avalable for the right fit.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

PLYMOUTH, MN, US, 55442

City:  PLYMOUTH
State:  MN
Country/Region:  US
Travel:  None
Requisition ID:  64242
Alternative Locations: 
Function:  Engineering & Technology


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Senior Quality Engineer, Manufacturing Engineer, Engineer, Engineering, Quality

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