Senior Quality System Project Engineer

Last updated 4 minutes ago
Location:Tualatin, Oregon
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.

Job Overview

The Sr Quality System Project Engineer is responsible for leading the effort to an aggressive timeline to combining two sites quality systems into one. This position will establish the plan to meet program timelines, implementing best practices and maintaining systems and/or services to measure and improve product quality, and customer service while ensuring full compliance to FDA QSR (21 CFR 820), and ISO 13485 requirements.

Responsibilities

  • Works closely with the Oregon Head of Quality, and the Oregon QMS manager to ensure that the quality management system is maintained to appropriate regulatory standards such as FDA QSR (21 CFR 820), and ISO 13485 requirements
  • Develop plan to get to a single Quality Manual for both the Metals and Interconnect businesses and that the policy and procedures are merged as needed for certification
  • Update documents to meet objectives
  • Ensures site certification is planned to allow shipments per project schedule
  • Develop a plan for all system back up and IT system transfer.
  • Lead the incorporation of identified best practices for the transfer that will improve efficiencies.
  • Creates Quality Plans and updates for the project objectives
  • Utilizes lean manufacturing (TEOA model), error proofing and continuous improvement initiatives to support the quality organization by assisting in development of robust processes and governing procedures that ensure quality products and service
  • Creates reports and drives action plans to meet project needs
  • Leads, mentors, and engages team members in project deliverables
  • Fosters an environment of team collaboration
What your background should look like:
  • BS Engineering degree preferred, scientific or engineering emphasis required
  • Five (5) or more years of work experience in a related regulated medical device environment preferred
  • Minimum of two (2) years previous project management experience is required with a proven track record of successful results
  • Six Sigma Green/Black belt desirable
  • ASQ membership recommended
  • Lead Auditor ISO 13485 certification a plus
  • Management and Leadership training desirable
  • Strong networking skills and ability to lead and influence others at all levels of the organization
  • Able to work effectively with individuals including internal and external customers, at all levels and widely varied disciplines
  • Strong skills in negotiation and influence
  • Ability to manage tight timelines and budgets, and changing/conflicting priorities
  • Excellent proven problem-solving techniques
  • Superior ability to effectively communicate both orally and in writing

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.