- Reference: GJ43946
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
Quality Assurance Manager will be required to support department goals and continuous improvement initiatives, prepare and are responsible for ensuring the quality of products during and after the manufacturing process. They are inspectors, statisticians, document recorders, researchers & facilitators. The person will report to and work closely with the CEO and will play a key contributing role within the Management Team. S/he must be able to adapt to a continually evolving environment and thrive in an autonomous and deadline-oriented workplace.
- Maintenance, improvement & streamlining of the Quality Management systems (QMS)
- GMP governance and training for the manufacturing site.
- GMP documentation management and approval.
- Daily GMP support for Departments outside of production areas.
- Quality Management System Reviews and other Quality performance reviews and provision of support for the Annual Product Quality Review process.
- Change Control.
- Internal and external inspection preparation and facilitation.
- Supplier Quality management, as appropriate
- Distribution Quality governance, Qualification/validation Quality approval, authorisation and execution of studies managed within the Department.
- Maintenance of the site master file, company licences and provision of Quality declarations and other Quality support information for Regulatory Affairs
Investigation, deviation and CAPA completion and support as relevant.
- Ensuring adequate Quality improvement plans.
- Quality support for projects and project delivery.
- Demonstrate best QA practices in line with the company objectives
- Manage the QA Test Lab & team.
Skills, Qualifications and Experience:
- Minimum 5 years Quality Assurance and new product introduction experience in Medical Device Manufacturing discipline.
- Preferred background in PTA/balloon catheters & coatings background
- Experience of working in a fast paced commercial environment
- Ideally a primary degree in Science/Engineering
- Working knowledge of Regulatory requirements facing a Medical device Producer.
- Excellent planning and organizational abilities.
- Must have the ability to communicate effectively with management and fellow peers.
- Pro-active with proven ability to work under own initiative, and strong team player.
- Demonstrated track record of Quality Assurance leadership in multi-disciplinary teams.
- Excellent presentation skills
- Experience in medical device sector & outstanding engineering/technical skills
For a confidential discussion and more information on the role/company please email your CV to:firstname.lastname@example.org