Quality and Reliability Engineering Manager

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

The Manager of Quality & Reliability Engineering within the IVD business of TE Medical will play an important role within the New Product Development, New Product Introduction (NPI), and Manufacturing teams. The individual will guide their team to ensure that products and manufacturing processes are developed to meet customer needs, in accordance with local site development QMS expectations and are, in turn, aligned with regulatory requirements expected of a medical device manufacturing organization.

The Manger of Quality & Reliability Engineering will be the quality compliance expert. Their team is in charge of guiding the NPD, NPI, and MFG projects by:

• Focusing on compliance and quality in the development of new products in the Devices business across the various sites within TE Medical.

• Guiding NPD projects through the development stages in accordance with the QMS and industry regulatory standards (ISO13485:2016 and 21CFR820)

• Guiding and mentoring a team of Quality & Reliability Engineers

• Collaborating with peer functional groups

Job Responsilites

• Apply best practice and proactive quality engineering principles to both the product and process development activity of within the NPD team.

• Guide project teams in project compliance to the QMS requirements as they are achieving the customer design and performance expectations.

• DOE – designing and executing experiments/testing to ensure a products meet requirements and a robust/reliable manufacturing process

• 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.

• Ensures all customers questions, concerns, and complaints are professionally addressed in a timely manner and escalates critical issues as appropriate, while delivering on an extraordinary customer experience.

• Participates in new product introductions to ensure quality is built into all products early in their life cycle.

• Reviews and consults on the design development of Design History Files (DHF) for new products and ensures regulatory compliance.

• Leads and demonstrates expertise in the areas of QSR and ISO standards within one’s own group, constantly promoting awareness of industry best practices and making appropriate decisions.

• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

• Utilizing the best-in-class problem solving tools, drives robust and effective corrective and preventive actions through the CAPA system.

• Demonstrates commitment to the Quality Policy (patient safety and product quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.

• Ability to work with a cross-functional team to develop and deliver on the site targets and objectives.

• Mentors and trains staff to perform effectively in their work and ensures the training is documented.

• Engages and manages a high-performance quality team of Quality & Reliability Engineers

• Creates a strong team and working environment with focus on customer needs, compliance, product quality, and risk mitigation.

• Develop talent by creating training and development plans with employee input into their career objectives

What your background should look like:

• Relevant Engineering Degree

• 8+ years experience in product/process development

• 3+ years managing high-performing teams

Key Requirements

• Previous medical devices 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, process development, and transfer to manufacturing 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, quality and technical focused collaboration, managing customer expectations a distinct advantage in the role

Competencies

Building Effective Teams

Motivating Others

Managing and Measuring Work

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

SET : 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 enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 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 (https://www.linkedin.com/company/te-connectivity/) ,Facebook (https://www.facebook.com/teconnectivity/) ,WeChat, (http://www.te.com.cn/chn-zh/policies-agreements/wechat.html) Instagram andX (formerly Twitter). (https://twitter.com/TEConnectivity)

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 Salary + Incentive(s) + Benefits

BENEFITS

• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets

Location:

Centennial, CO, US, 80111

City: Centennial

State: CO

Country/Region: US

Travel: Less than 10%

Requisition ID: 123506

Alternative Locations:

Function: Quality

TE Connectivity and its subsidiaries, affiliates, and operating units (collectively, the "Company") is committed to providing a work environment that prohibits discrimination on the basis of age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation.