GMIL are Hiring
Goodman Medical Ireland Limited (GMIL) is a progressive and dynamic manufacturer of medical devices, mainly concerned with the development and manufacture of cardiovascular devices and implants. GMIL has been operating successfully since 2004 and we have built our success on the belief that finding, employing and continually developing the right people is one of the keys to building a safe and effective medical devices. We are currently recruiting for the below positions.
The successful candidate will be working in the manufacturing area providing real time Quality Assurance support to the production line. This will include the implementation of process controls, CAPA systems and day to day problem solving. Work within the Core Team structure to manage the production lines.
Major Duties & Responsibilities:
The role will involve the responsibility for the following:
- Responsible for providing hands on line support to the catheter and balloon production lines acting as a key member of the Core line support team.
- Demonstrate the ability to work with the Core Teams, Line Leads and Engineering Support and the Senior Quality Engineer.
- Actively implement quality systems and standards.
- Responsible for ensuring effective & efficient line handover from day-mid-day shifts by providing good communications on line issues & quality items.
- Responsible for direct involvement & leading continuous improvement projects and initiatives.
- Responsible of the preparation & maintenance of quality metrics and reporting systems.
- Responsible for preparation of quality reports for presentation at quality meetings and management reviews.
- Responsible for provision of support to the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements.
- Acts as an effective team member in supporting quality disciplines, decisions and practices.
- Applies sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues and leading problem solving.
- Ensures regulatory compliance to GMP for all medical device regulatory agencies.
- Demonstrates the ability to identify process & changes in procedures and standards to facilitate work efficiency and maintain quality.
- Responsible for reporting on functional area quality metrics.
- Responsible for conducting internal quality audits to ISO and GMP requirements.
- Responsible for initiating and completing Non Conformance reports & investigations.
- Excellent interaction and communication skills across functions.
Qualifications and Education Requirements:
- Min 2 years industry experience in a medical device manufacturing /cleanroom environment in a QA Role.
- Science/ Engineering/Quality Degree and relevant experience (Level 7 min).
- Strong commitment to Quality, Safety, GMP & GDP.
- Good understanding of problem solving methodologies is required.
- Good level of experience within a hands on line support type role is required.
- Strong attention to detail and developed technical report writing skills.
- Excellent Computer Skills (Word, Excel, PowerPoint and Access).
- Excellent Communication (both verbal and written) & interpersonal skills.
- Experience with team work and working with other functional roles.
- Flexible, highly motivated individual, positive attitude.
To submit CV: Simply complete the form below and attach your CV and cover letter, or email our Human Resources Department at firstname.lastname@example.org