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Quality Systems Manager

 

Company Information

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 nearly 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedInFacebookWeChat and Twitter.

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.

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 ISO 13485 requirements.  This position will be responsible for the continual improvement and maintenance of our current quality system.

Responsibilities

  • 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 ISO 13485 requirements
  • 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 Plans for harmonization and integration of both site quality management systems and carries out plan
  • Ensures relevant corporate and site quality 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 and governing procedures that ensure quality products and service
  • Responsible for the site Corrective and Preventive Action (CAPA) system, ensuring corrective actions are effective and completed with timelines and practices in accordance with policies
  • Responsible for the Internal Audit program management and ensuring audits are completed on time
  • Lead internal and external (customer, notified body, regulatory authority) audit activities as required
  • Assists Training Manager with implementation of sites’ Training Programs
  • Responsible for sites’ Documentation Control
  • Works with the Global Supplier Quality Assurance team to ensure site supplier quality activities are completed in accordance with policies and procedures and site compliance is maintained to regulatory standards
  • Responsible for performance management and the hiring of the employees within the Quality Systems and Documentation Control departments
  • Leads, mentors, and engages direct reports for continuous improvement of systems and personnel
  • Fosters an environment of team collaboration with the site and amongst TE Medical sister sites

Qualifications

  • 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 experience managing /supervising engineers/technicians is required with a proven track record
  • 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 facilitate the development of direct reports
  • 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

What TE Connectivity Offers

We offer a competitive “total rewards” compensation. Our commitment to our associates includes offering benefit programs that are comprehensive, competitive, and meets the needs of our employees.

 

  • Generous 401(k) Plan
  • 100% 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: 

Tualatin, OR, US, 97062

Alternative Locations: 
Travel:  10% to 25%
Requisition ID:  43893


Nearest Major Market: Portland Oregon

Job Segment: Engineer, Developer, Law, CAPA, Quality, Engineering, Technology, Legal, Management

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