The Senior Operations Quality Engineer is a member of the Operations Quality group, who will report to the Operations Quality Manager. 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. 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.
- 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 organizations 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 organizational skills and ability to work on own initiative essential.
- Supervisory experience desirable.
- Excellent written and verbal communication skills essential
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent