Quality Manager

Job Overview

TE Connectivity's Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release.

The Quality Control Manager - Manufacturing role is working for the Invitro Diagnostics (IVD) group of TE Medical's business unit within the Industrial Solutions sector. The Quality Control Manager will play an important role within the Manufacturing teams, and work with the NPI and NPD teams. The Quality Control Manager will guide their team to ensure that products and manufacturing processes are developed that meet customer needs, developed in accordance with local site development QMS (Quality Management System) expectations and are, in turn, aligned with regulatory requirements expected of a medical device manufacturing organization. This position will be onsite at our Parker, CO location.

Responsibiites:

•    Responsible for Quality Control activities related to the manufacturing of medical device components.
•    Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product and deviations.
•    Ensures all customer queries, concerns, and complaints are professionally addressed in a timely manner and escalates critical issues as appropriate, while delivering an extraordinary customer experience.
•    Ensures compliance to the quality management systems in all activities performed.
•    Participates in new product introductions to ensure quality is built into all products early in their life cycle.
•    Reviews and consults on design & development projects, particularly, the development of the Design History File (DHF) for new products and ensures regulatory compliance.
•    Leads and supports external audits from external sources including preparation activities in advance of such audits.
•    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.
•    Utilizing the best-in-class problem solving tools, drives robust and effective corrective and preventive actions through the CAPA system.

Building Effective Teams & Motivating Others
•    Engages and manages an international, high-performance quality team including Quality Inspectors, Quality Engineers, and Supplier Quality Engineers. 
•    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 strategic targets and objectives.
•    Mentors and trains staff to perform effectively in their work and ensures the training is documented.
•    Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation. 
•    Develop talent by creating training/development plans with associated input into their career objectives

Strategy, Execution, Talent
•    Work with leadership team to develop strategic plans for obtaining annual objectives and goals. 
•    Measures and monitors key process indicators to proactively evaluate the execution of the strategic plans developed.  
•    Develops and retains the staff that contribute to achieving the goals and objectives of the organization.
 

What your background should look like:

• Bachelor’s degree in related field of Engineering or Science
• 8+ years' total professional experience required; including 2+ years in a regulated, manufacturing environment 
• 2+ years’ experience managing / supervising teams of Engineers / Technicians 
• Previous medical devices experience in support of development or operations manufacturing in a medical devices industry operating under a certified QMS environment is preferred.. 
• Ability to apply a structured problem-solving approach and Six Sigma tools and familiarity with these methodologies 
• Good people skills and the ability to work with different personnel skillsets within the Company. cross-functionally
• ASQ Certified Quality Engineer or MS degree, preferred
• Six Sigma Green/Black belt, preferred

Competencies