Quality Manager

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, assess 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.

Responsibilities:

• Managing and Measuring Work
  • Ensures compliance to the quality management systems in all activities performed within Creganna Medical
  • Leads and supports audits from external regulatory agencies (FDA, BSI, JPAL) and customers and to lead preparation activities in advance of such audits.
  • Ensures all customer queries and concerns 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.
  • Oversees 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
  • Participates and leads in an active role the execution of the site's TEOA Program.
• Building Effective Teams & Motivating Others
  • 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.
  • 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. 
  •  Develop talent by creating training and development plans with associate input into their career objectives.
• Strategy, Execution, Talent
  • Work with site leadership team to develop strategic plans for obtaining annual objectives and goals.  
  • Measures and monitors key process indicators to proactively evaluate the execution of meeting and/or exceeding the strategic plans developed.  
  • Develops and retain the associates that contribute to the success of obtaining the goals and objectives of the organization.
     

• BS/BA degree with a scientific emphasis required. 
• Minimum of eight (8) years' work experience in a related regulated medical device environment. 
• ASQ Certified Quality Engineer or MS degree preferred. 
• Six Sigma Green/Black belt preferred. 
• Good people skills and the ability to work with different personnel skillsets within the Company.