Ref No: AM17925
County Wicklow, Republic of Ireland
Quality Engineer Team Lead - North Wicklow.
The overall purpose of this job is to provide guidance on all aspects of manufacturing systems including support in the management of QA activities for supply chain of products, to ensure that product and processes meet the required specifications and duties are performed within the regulations.
To assist the Head of QA and QS in the management of corrective action systems and internal audit actions to deliver timely and adequate investigations and appropriate actions.
To assist in the promotion of Quality System usage and compliance to avoid non-compliance in external audits and avoidance of product problems in the market/recalls.
Support the Quality Engineers with Quality Event and Audit action activity and information discussion.
Support QA Document activities and Product Release activities.
Support and engage in the internal and external audit programmes, as appropriate.
Support the Supply Chain activity on regulatory and quality requirements to ensure consistent product supply is maintained and all quality aspects are met.
Ensure that non-conforming equipment, suppliers, manufacturing activities, reworks and testing activities are noted and addressed for appropriate actions to ensure that product safety and effectiveness is addressed.
Actively support, monitor and drive participation in the Investigation Management System across the product lifecycle, including investigation and management of customer complaints.
Responsible for Quality Event and Internal Audit action investigation, corrective action and disposition approval including verifying that subsequent activities do not adversely affect the ability to meet applicable regulatory requirements.
Responsible for rework activity review and approval, as appropriate.
Assist in the review of product and process changes to maintain and meet regulatory guidelines.
Support review of risk management files as required.
Work constructively with team members from cross-functional teams, Supply Chain, R&D, Marketing, and Technical Support group to attain outcomes.
Communicate progress on a frequent basis and maintain metrics, as needed.
Qualifications and experience required:
An advanced life science degree with experience in medical devices or biological sciences
At least 2-5 years or more industrial experience, of which three years has been in the diagnostic/medical device/pharmaceutical industry
Demonstrated competence in biochemical techniques and statistical concepts
Demonstrated knowledge of ISO 13485 and MDSAP requirements