Job Description

  • Employment Type:
  • Job Location: Galway
  • Date Posted: Posted 1 year ago

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 – www.TE.com.

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.  http://www.creganna.com/

Senior Quality Engineer – Operations

Reports To: Operations Quality Manager

Primary Objectives of Position:

    • The Senior Operations Quality Engineer is a member of the Operations Quality group.

 

    • S/he is responsible for Operations Quality within their prescribed area of functional responsibility.

 

    • The successful candidate will lead and work as part of a team to maintain high quality / performance standards on all Creganna Medical products.

 

    • Reporting to the Operations Quality Manager, the position will be challenging and will require an ability to lead a team and work on own initiative and with minimum supervision.

 

 

Major Accountabilities:

    • Lead and drive QA initiatives within area of functional responsibility.

 

    • Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.

 

    • Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.

 

    • Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.

 

    • Strategically lead new product introduction and contract reviews from a QA perspective.

 

    • Preparing and updating Operations procedures and associated documentation.

 

    • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness.

 

    • Establishing inspection standards, plans, frequencies and test methods.

 

    • Reporting functional are Quality metrics.

 

    • Preparation of Quality reports for Operations meetings and management reviews.

 

    • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements

 

    • Develop strong links with customer organisations and other project stakeholders.

 

    • Understanding of standard metrology good practice.

 

    • Quality review of functional area validation documentation.

 

    • Performing and supporting internal and external audits to ISO and FDA requirements.

 

    • Performing an active role in further development and continuous improvement of the quality management system.

 

    • Support Operations area projects and initiatives i.e. Kaizen, CFPS etc.

 

    • Supervision and direction of Quality personnel.

 

    • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.

 

Requirements:

    • Degree in Science / Engineering or related fields essential

 

    • Minimum of 5yrs industry experience in a medical device-manufacturing environment.

 

    • Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.

 

    • Strong CAPA experience.

 

    • Strong root cause analytical and problem solving skills.

 

    • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.

 

    • New product introduction and manufacturing process transfer experience desirable.

 

    • Demonstrated excellent organizational skills and ability to work on own initiative essential.

 

    • Supervisory experience desirable.

 

    • Excellent written and verbal communication skills essential.

 

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