Senior Quality Systems Supervisor (Temp)
Athlone, County Westmeath
At our quality department in Athlone, we focus on ensuring that our customers get the best quality products by continuously improving our processes and systems whilst meeting all quality and regulatory compliance requirements.
The Senior Quality Systems supervisor role is directly involved in fulfilling this purpose.
* Provides oversight for the development and maintenance of quality programs e.g. the CAPA system that ensure compliance with policies and that the performance and quality of such systems conform to established internal and external standards and guidelines.
* Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of site audits
* Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
* Ensures that quality assurance programs e.g. site supplier quality program and policies are maintained and modified in line with corporate and regulatory requirements
* Prepares reports and/or necessary documentation e.g. CAPA documentation and provides to applicable stakeholders both internal and external.
* Act as site SME for the Internal Audit, Supplier Quality, CAPA and Complaint
KEY SKILLS & EXPERIENCE
* A minimum of Level 8 degree in a science or engineering discipline.
* Preferably 4-6 years relevant experience in a medical devices or similar regulated environment, with at least 3 years in a comparable role.
* Strong working knowledge of quality systems and the regulatory standards that govern the manufacture of medical devices.
* Results driven and dynamic team player and can work effectively and proactively on cross-functional teams.
* Ability to be self-directed and to effectively interface with various levels and functions within the organization.
* Excellent organizational skills and have the ability to prioritize and work effectively on multiple projects and to provide tactical and or/technical leadership.
* Strong computer literacy skills, advanced working knowledge of Excel desirable
* Excellent communication and influential skills in order to communicate with internal an external customers and vendors across various levels of the organization. Ability to share and exchange relevant information to reach solutions and gaining cooperation of other parties.
Renumeration: An excellent Salary/Benefits on offer and negotiable
Please forward your CV in word format to:
Informal inquiries to Christy O'Hara on 087-9473404 or 00353 879473404 if outside Ireland