Quality Manager NPD

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

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Job Overview

Quality Manager - NPD within the Invitro Diagnostics (IVD) business of the TE Medical business unit will play an important role within the New Product Development (NPD) and New Product Introduction (NPI) teams. The individual will guide teams to ensure that products and manufacturing processes are developed that meet both what the customer needs, developed in accordance with local site development QMS expectations and are, in turn, aligned with regulatory requirements expected of a medical device manufacturing organization. This is a US remote role.

The Quality Manager in New Product Development group will be the quality compliance expertise in the NPD group, and responsible for guiding to the overall NPD project delivery model as well as project teams themselves in areas of: 

•    Guiding a compliance and quality focus in the development of new products in the Devices business across the various sites within TE Medical. 
•    Guide the Quality input to NPD project planning through development phases in accordance with the QMS and industry regulatory standards (ISO13485:2016 and 21CFR820)
•    Guiding and mentoring a quality team within NPD and collaborating with peer functions 

Job Responsibilities
•    Guide project teams in maintaining project to the QMS requirements as they are achieving the customer design and performance expectations. 
•    Ensure that the new product development project is effectively planned, that it considers all applicable quality and regulatory for design and development planning, and a successful project completion.
•    Provide the guidance for the NPD Project teams, to maintain project development activity in accordance with requirements of ISO13485:2016, and 21CFR820 for design and development controls. 
•    Support the design control assurance objectives of the project team and the customer, to deliver on the required design history file elements in the phase of product and process development.  
•    Ensuring that project can be transferred to a commercial manufacturing scale with appropriate risk management applied within its development and for continued manufacturing. 
•    Apply best practice and proactive quality engineering principles to both the product and process development activity of within the NPD team. 
•    Manage a Quality & Reliability Engineering team across multiple sites.
 

What your background should look like:

•    Bachelor's degree in Engineering or Science discipline
•    8+ years’ experience in medical device; with 2+ years in a supervisory / managerial position leading engineers / technicians
•    Previous medical device experience in support of development or operations manufacturing in a medical devices industry operating under a certified QMS environment is essential
•    Experience in a similar manager role involving new product development is a distinct advantage
•    Ability to apply a structured problem-solving approach and Six Sigma tools and familiarity with these methodologies
•    A Six Sigma certification (Green/Black) is an advantage
•    Proficient in technical communication, and with a strong attention to detail is necessary.
•    Experience in customer interaction, and involving quality and technical focused collaboration, that can establish customer expectations, and while also to resolve customer design and manufacturing challenges is a distinct advantage in the role
 

Competencies

Building Effective TeamsMotivating OthersManaging and Measuring WorkValues: Integrity, Accountability, Teamwork, InnovationSET : Strategy, Execution, Talent (for managers)

ABOUT TE CONNECTIVITY
TE Connectivity is a 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 more than 85,000 employees, including more than 7,500 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.

COMPENSATION
•    Competitive base salary commensurate with experience: $94,000 – $141,000 (subject to change dependent on physical location)
•    Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
•    Total Compensation = Base