Quality Assurance Manager II

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

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.

Responsibilities

Managing and Measuring Work
o Ensures compliance to the quality management systems in all activities performed within Creganna Medical
o Leads and supports audits from external regulatory agencies (FDA, BSI, JPAL) and customers and to lead preparation activities in advance of such audits.
o Ensures all customer queries and concerns are professionally addressed in a timely manner, and escalates critical issues as appropriate.
o Promotes customer satisfaction and delivers on an extraordinary customer experience.
o Develops and delivers process improvements that reduce cost or improve the quality of the product.
o Develops a strong working relationship with internal and external customers.
o Participates in new product introductions to ensure quality is built into all products early in their life cycle.
o Oversees the design development of Design History Files (DHF) for new products and ensures regulatory compliance.
o Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
o 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.
o Drives continuous improvement initiatives to enhance the site quality system and product quality while ensuring compliance to governing regulations and corporate policies and procedures.
o Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
o Utilizing the best in class problem solving tools, drives robust and effective corrective and preventive actions through the CAPA system.
o Understands and complies with all regulations governing the quality system.
o Facilitates root cause investigations for quality issues.
o Manages all quality related activities for finished device manufacturing and participate in Site & Corporate initiatives.
o Participates and leads in an active role the execution of the site’s TEOA Program.

Responsibilities, cont.

Building Effective Teams & Motivating Others
o 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.
o Ability to work with a cross-functional team to develop and deliver on the site strategic targets and objectives.
o Mentors and trains staff associates to perform effectively in their work and ensures the training is documented.
o Engages and manages a high performance quality engineering team. Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation.
o Promotes quality in the organization and motivates others towards their commitment to patient safety and product quality.
o Develop talent by creating training and development plans with associate input into their career objectives

Strategy, Execution, Talent
o Work with site leadership team to develop strategic plans for obtaining annual objectives and goals.
o Measures and monitors key process indicators to proactively evaluate the execution of meeting and/or exceeding the strategic plans developed.
o Develops and retain the associates that contribute to the success of obtaining the goals and objectives of the organization.

What your background should look like:

• BS/BA degree with a scientific emphasis required.
  
• ASQ Certified Quality Engineer or MS degree preferred.
  
• Six Sigma Green/Black belt preferred.
  
• Minimum of 12 years’ experience in a related regulated medical device environment, with 4 years in supervisory or managerial role.
  
• Good people skills and the ability to work with different personnel skillsets within the Company.
  

Competencies