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Staff Supplier Quality Engineer

Posted on May 1, 2020 by Real Staffing Group

Galway, Ireland
Engineering
Immediate Start
Annual Salary
Full-Time

Title: Staff Supplier Quality Engineer

Location; Parkmore, Galway

Benefits: Exciting career progression opportunity, Excellent salary, pension, healthcare and yearly bonus on offer.

Role:

As a Staff Supplier Quality Engineer is a member of the Supplier Quality Engineering team. You are responsible for Supplier Quality within their prescribed area of functional responsibility working as part of a team to maintain high quality/performance standards. 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.

Company:

My client is ranked among the top 10 global companies in the medical device outsourcing industry, they specialize in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Headquartered in Galway, they has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.

Responsibilities

  • Supervision and direction of Supplier Quality personnel (Engineer and Technician grade).
  • Lead and drive Supplier QA initiatives within area of functional responsibility.
  • Provide supplier quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
  • Investigating root cause of supplier issues (SCAR) and ensuring follow-through of timely and effective corrective actions to prevent re-occurrence.
  • Strategically lead new material introduction and support new product launches to ensure Supplier Quality meets the required standards.
  • Lead and support (as an auditor) various audits of a diverse supplier base.
  • Perform on site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues.
  • Reporting functional Supplier Quality metrics.
  • Preparation of Supplier Quality reports for various meetings and management forums.
  • Review Supplier Manufacturing processes. Collaborate with suppliers on process improvement and value enhancement opportunities.
  • Facilitate the escalation of unresolved Supplier Quality issues.
  • Take ownership of the Material Review Board process within the Galway site.
  • Lead a team of incoming inspectors ensuring the quality of supplied components meet the company's requirements.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
  • Develop strong links with customer organizations and other project stakeholders.
  • 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.
  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives

Qualifications

  • Level 8 degree in Science/Engineering or related fields essential.
  • Minimum of 5 years industry experience in a medical device manufacturing environment.
  • Must have a working visa for Ireland

If you would like to know more about this exciting position forward me a copy of your up to date CV and we can organise a call to discuss in more detail.

Looking forward to hearing from you.

Key Requirements

  • 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, ISO & MDSAP Quality system regulations for Medical device companies desirable.
  • Auditor certification and experience desired.
  • Supervisory experience desirable.
  • Experience in development and coaching.
  • Excellent written and verbal communication skills essential.
  • Willingness to travel

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales

Reference: 884892014

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