A Major Medical Devices Company in Galway City, Ireland is seeking to fill the post of
PROGRAM MANAGER - COMPLIANCE
You will be responsible for leading the compliance and continuous improvement activities within the Technical Services function.
You will provide governance and leadership to establish best practice in accordance with ISO13485, 21 CFR and Corporate Quality standards and Regulatory requirements.
You will partner with Subject Matter Experts (SMEs) to establish best in class systems and procedures for maintenance of site general, electrical and mechanical equipment, cleanroom validations, equipment and software validations.
You will ensure that all applicable regulatory requirements are reflected in internal documentation and implement changes when requirements are revised in accordance with documentation and industry best practice.
You will establish a comprehensive system to support investigations for CAPA's, MIR's and Technical Services investigations to address root causes and systemic issues, cultivating and imbedding these competencies within the function.
You will coach and develop team members in supporting internal and external audits of the Technical Services Function. You will lead the continuous improvement strategy and change management for the function, maintaining performance reports and KPI's.
You must be capable of leading and driving projects / sub-projects as necessary.
Degree level in Engineering / Science or related discipline, with 7-10 years' experience working in quality, compliance, validations.
Experience in problem solving techniques including DMAIC is an advantage.
A dynamic team player and leader and can work effectively and proactively on cross-functional teams.
Experienced in PowerPoint, Excel Word etc.
Good communication, organizational, presentation and leadership skills are desirable with a high level of enthusiasm and motivation.
A good communicator and fluent in English, both in writing and speaking.
REMUNERATION: An excellent Salary/Benefits on offer and negotiable
Please forward your CV in WORD FORMAT to:
Informal enquiries to Christy O'Hara on 087-9473404 or 00353 879473404 if outside Ireland