Quality Systems Manager

Last updated yesterday
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 Quality Systems Manager is responsible for establishing, implementing 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 applicable ISO 13485 requirements, SOR 98/28 (Canada) CMDCAS, Korean Medical Device Act (MDA) Law No. 6909, Ordinance 269 (Japan), and EU MDR 2017/745 and other relevant quality requirements and standards.

What you will be doing:
  • Works closely with the Site Head of Quality at two site locations within TE Medical ensuring that the quality management system is maintained to appropriate regulatory standards such as
  • FDA QSR (21 CFR 820), and applicable ISO 13485 requirements, SOR 98/28 (Canada) CMDCAS, Korean Medical Device Act (MDA) Law No. 6909, Ordinance 269 (Japan), and EU MDR
  • 2017/745 and other relevant quality requirements and standards
  • Responsible for the Quality Management System at both locations
  • Identifies process gaps and ensures policies/procedures are implemented to fulfil the organizational business strategy
  • Creates Quality Plan for harmonization and integration of both site quality management systems and carries out plan
  • Ensures relevant corporate policies and procedures are implemented, maintained and adhered to
  • Prepares Management Review information for the sites and provides site information for Global/Corporate Management Reviews
  • Promotes awareness of applicable regulatory requirements and quality management system requirements throughout the organization
  • Exudes customer-focused attention to deliver TE’s Extraordinary Customer Experience
  • Utilizes lean manufacturing (TEOA model), error proofing and continuous improvement initiatives to support the quality organization by assisting in development of robust processes that
  • assures quality products and service
  • Works closely with Customer Service and Quality Engineers to maintain and improve Complaint Handling and the implementation of the RMA system
  • Responsible for the site Nonconformance and Corrective and Preventive Action (CAPA) system, ensuring corrective actions are effective and completed with timelines in accordance with
  • policies
  • Responsible for the Internal Audit program ensuring audits are completed on time
  • Lead internal and external audit activities as required
  • Responsible for eQMS implementation at both sites
  • Responsible for sites’ Training Programs
  • Responsible for sites’ Document Control
  • Works with the Global Supplier Quality Assurance team to ensure site supplier quality activities are completed in accordance with policies and procedures
  • Responsible for the implementation and review of activities related to the engineering change order and notification process, and external documents
  • Responsible for performance management and the hiring of the employees within the Quality Systems department
  • Leads, mentors, and engages direct reports for continuous improvement of systems
  • Fosters an environment of team collaboration
What your background should look like:
  • BS/BA, or Engineering degree with a scientific or engineering emphasis required
  • Minimum of ten (10) years of work experience in a related regulated medical device environment
  • Minimum of two (2) years previous experience managing /supervising engineers/technicians is required with a proven track record
  • Finished Device manufacturing experience required
  • Six Sigma Green/Black belt desirable
  • ASQ Senior member recommended or MS degree desirable
  • 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 facilitate the development of direct reports
  • Ability to manage tight timelines and changing priorities
  • Excellent problem-solving techniques

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.