You will be responsible for assessing, improving and
maintaining company Quality System, policies and procedures to ensure all processes, components, subassemblies and finished products are manufactured in compliance with applicable FDA and ISO requirements.
Implementation of ISO13485 in Ireland operation
Manage and maintenance of Quality System in full compliance with ISO
13485 and FDA QSR.
Plan, recruit, develop and manage the talents for the Quality team and the Quality Inspection Team in Irish operation.
Lead Quality Assurance activities, including but not limited to:
Internal and external audit/complaint handling/supplier management evaluation/NCMRs/CAPAs/management reviews/product release and document control
Develop and Manage complaint handling process between Ireland and
Develop and Manage the Non-conforming Materials Review (NCMR)/ Deviations program in collaboration with Operations to ensure timely reporting, analysis, and resolution of non-conforming material/ product incidences.
Conduct supplier evaluation and audit.
Develops, reviews and approves validation and calibration master plan. Interface and support audits by external regulatory bodies and follow-up activities to ensure the credentials.
7-10 years quality assurance/engineering experience in the Medical Device industry.
Minimum of five years QA Management experience required
Degree in life sciences, Engineering or equivalent
Ability to motivate and influence people
Organizing, planning, and problem-solving skills
Good interpersonal and communication skills.
Ability to work as a part of a team
Good statistical and numerical ability
Knowledge of FDA and ISO regulatory requirements and guidelines related to medical devices
Great attention to detail