Staff Supplier Quality Engineer
Posted on May 1, 2020 by Real Staffing Group
Title: Staff Supplier Quality Engineer
Location; Parkmore, Galway
Benefits: Exciting career progression opportunity, Excellent salary, pension, healthcare and yearly bonus on offer.
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.
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.
- 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
- 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.
- 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