Job Description

TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. Our connectivity and sensor solutions are essential in today’s increasingly connected world. We collaborate with engineers to transform their concepts into creations – redefining what’s possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS – .   

Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.

Quality Operations Manager

Job Description:

  • To proactively protect the customer through ensuring that all products are manufactured to the highest standards and under the highest GMP conditions.
  • 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.
  • Manage all quality related activities for finished device manufacturing and participate in Site & Corporate initiatives.
  • Understands and complies with all regulations governing the quality system. 
  • Ensures the quality operations team are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Job Responsibilities:

  • Leads and demonstrates expertise in the areas of QSR and ISO standards within one’s own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis.
  • Ensure compliance to the quality management system in all activities within Creganna-Tactx.
  • To support audits from external regulatory agencies (FDA, BSi) and customers and to lead preparation activities in advance of such audits.
  • Ensure all customer queries and concerns are professionally addressed in a timely manner.
  • Drives continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures. 
  • Develops 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.
  • Delivers process improvements that reduce cost or improve the quality of the product.
  • Develop strong links with customer organisations.
  • Participate in new product introductions to ensure quality is built into all products early in their life cycle.
  • Ensure effective and efficient process controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • Participates in Customer Complaints investigation for areas under their control and escalates critical issues as appropriate.
  • Drives robust and effective corrective and preventive action programs through the CAPA system.
  • Provides best in class problem solving tools.
  • Facilitates root cause investigations for online QA issues.
  • Expected to play active role in the execution of the site Quality Excellence Program particularly those projects identified to drive quality system effectiveness.
  • Works cross-functionally to deliver on the site strategic targets and objectives.
  • Ensures staff are trained to perform effectively their work and their training is documented.

Working Conditions

  • The majority of the work will be spent on-site in an manufacturing / cleanroom environment
  • There may be a requirement as part of the role to travel.

Key Requirements:

  • A graduate of Engineering, Sciences or equivalent qualification.
  •  Proven track record in a similar role with a minimum of 5-8 years’ experience at that level within the Me
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