What you need to know
A leading medical device company with global operations that is experiencing strong growth is seeking an experienced and committed Quality Systems Engineer to join its team in Co. Leitrim.
The company has an outstanding track record in designing, developing, and manufacturing cutting-edge medical device products that improve patients’ lives. The company is committed to delivering innovative products and prides itself on its industry-leading quality, lean manufacturing, and processing technologies.
As a Quality Systems Engineer, you will report directly to the Quality Manager on-site and work to ensure that the company’s quality systems are maintained to the highest of standards and that product quality and documentation processes are adhered to.
This is a permanent role with an excellent salary and benefits.
Your new job
Key duties & responsibilities:
Coordination, maintenance, and integration of the Quality Management System with all processes in accordance with the requirements of ISO 13485 regulations.
Establishing, implementation and maintenance of processes necessary for the Quality Management System.
Assist in the generation of reports to be presented to management on the performance of the Quality Management System.
Participate in Management Review Meetings and assist in the compilation of the management Review presentation slides and minutes.
Assist in the coordination & maintenance of the Customer Complaint investigation process, vigilance reporting requirements, MDR requirements, and product recalls.
Assist with the coordination & maintenance of the Plant Corrective & Preventive action programme.
Participation and maintenance of plant Continuous process improvement programmes.
Participate in Root Cause Analysis process when required.
Manage Internal Quality and Environmental Audit programme and participate in the Vendor Management process.
Maintain, review & approve Quality System Policies.
Controlling the implementation and release of Procedures & documents that are impacting the Quality Management System (QMS).
Perform system and document updates to the QMS and EMS arising from changes to the corporate procedures.
Raising corporate Change Orders when required.
Review and approval of Customer Finished goods labels when required.
What are we looking for?
A minimum of 5 years experience in Quality System Administration in the Medical device Industry.
Good knowledge of ISO 13485, FDA QSR 21 CFR Part 820 regulatory standards, and the Medical Device Directive 93/42 EEC.
Good Knowledge and understanding of cGMP and GDP.
A Qualified Lead Auditor.
Experience in conducting and reporting on Vendor Audits.
Experience in managing/participating in Internal and external Audits.
Experience in completing Change management processes (Change Control).
Experience in managing &/or participating in a variety of Quality System processes, CAPA, NCMR, Deviations, SCARS etc.
Have excellent analytical and problem-solving skills with the ability to offer innovative solutions to challenges.
Strong organisation skills and the ability to prioritise tasks effectively and meet deadlines.
Be able to handle multiple projects and prioritise your own work.
Strong communication skills (oral and written).
Enthusiastic and results-orientated with good teamwork skills.
Apply for this job now by sending a Word version of your CV or get in touch with Oliver at firstname.lastname@example.org
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