Our client, a medical device company in Galway is currently looking to recruit an Senior Quality Engineer – Operations for their site.
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 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.
Key Responsibilities of the Position:
- 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.
- 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 organisational skills and ability to work on own initiative essential.
- Supervisory experience desirable.
- Excellent written and verbal communication skills essential.
For further information on Quality Engineer role in Galway please contact Orla Crowley Healy on 086 0449473 /Talent@hero.ie
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