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Quality Systems 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

As Staff Global Quality System Engineer, you will;

  • Implement and manage global quality system processes in TE Medical
  • Work closely with site quality teams to ensure harmonized quality system processes are implemented and effective, serve the business, and meet regulatory requirements
  • Develop and lead cross-site activities and drive best-practice adoption
  • Have and maintain a thorough awareness of relevant current international Medical Device regulations including US FDA QSRs and ISO13485:2016.
  • Be the SME and process owner for global Quality System processes, such as Internal Audits, Management Reviews, and CAPA. Develop and deliver QMS training as required.
  • Drive harmonization of QMS processes; work with global sites to develop implementation plans, ensure site activities are completed as planned, monitor implementation and effectiveness.
  • Carry out training on harmonized processes as required.
  • Help develop the QMS harmonization strategy; understanding individual sites maturity, compliance risks, other competing activities etc.
  • Organize both scheduled and unannounced QMS audits across global sites to ensure regulatory compliance.
  • Work with cross-functional and cross-site teams to improve quality system processes.
  • Implement changes to the QMS as driven by internal and external factors.
  • Coordinate management review activities; ensure site-level reviews are consistent and feed into executive/global reviews.
  • Participate in Quality System integration and harmonization activities for new sites and businesses as acquired.
  • Bench-mark and network within TE and outside the company to develop new ideas, and drive these to execution. Drive cross-site best practice sharing.
  • Drive awareness of current regulatory audit ‘hot-topics’ by keeping current on external reports and information; share this information globally.
  • Ensure all sites are “audit ready”.
  • Assist or lead during significant audits, as required.
  • Provide guidance to the business on QSR/ISO requirements.
  • Perform other job-related duties as assigned.

 

Click here to learn more about Life at TE.

TEGTA19

What your background should look like:
  • Bachelor's degree in Engineering, Science or related area.
  • Minimum 10 years in a regulated industry, ideally in a multinational medical device environment.
  • Certified lead auditor, with significant audit experience.
  • Experienced in regulatory audit preparation and participation.
  • Minimum 5 years Quality System experience at senior QE level.
  • Ability to manage non-routine projects of moderate complexity.
  • Thorough knowledge and experience with FDA/GMP/QSR and ISO 13485.
  • Excellent interpersonal skills – must be able to understand the opinions and perspectives of internal and external stakeholders and influence others without authority.
  • Manage multiple tasks and accomplish them in a timely manner.
  • Highly organized with strong ability to prioritize tasks and work on own initiative.
  • Ability to evaluate information gathered from observation, experience, reasoning, and/or communication, demonstrated clarity, accuracy, precision, independent judgment and thoroughness.
Work Location

This position can be at any TE Medical site globally, preferably in the US: Wilsonville, OR | Medway, MA | San Jose, CA | Campbell, CA | Plymouth, MN

About TE Connectivity
TE Connectivity Ltd., is a $14 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 80,000 employees, including more than 8,000 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: 

Wilsonville, OR, US, 97070

Travel:  10% to 25%
Requisition ID:  53493
Alternative Locations:  Medway, MA | Plymouth, MN | San Jose, CA | Campbel


Nearest Major Market: Portland Oregon

Job Segment: Quality Engineer, Manufacturing Engineer, CAPA, Engineer, Quality, Engineering, Management

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