Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845 Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
Completion of Validation Programme - Risk Analysis, VMP, Q's, OQ's, PQ'S as required according to procedure QAP and other related procedures.
Technical report writing to support completed Validation Programmes.
Review and Release of batch paperwork for Product release.
Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault ThreeAnalysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc, to the development of new products or processes related to raw materials, services, and finished products.
Support for NPI Quality - Deviations, non-conformances, root cause investigation/analysis, CAPA writing and reviewing.
Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
Qualifications arrow_right
Skills and Experience:
Highly Effective and articulate communication skills with an ability to convey and link with people at all levels of the organisation.
An ability to work cross functionally as this role requires interaction with different functions across the Group.
Demonstrates a behaviour of high performance and creates an environment of high engagement within the NPI Team.
Project Management of NPI & PD projects using appropriate methods and tools. (e.g. PMBOK, Agile PM Methods)
Six Sigma – lead problem solving and process improvement projects of medium to high complexity.
Proficient and proven experience of Product and Process Validation.
Qualifications:
Process experience in Grinding, Moulding, EDM and/or Laser processes – Distinct Advantage.
Degree in Engineering/Manufacturing/Quality with emphasis on Devices/Biomedical.
Ideally 4-5 years previous experience as Quality/Validation Engineer in Medical Device/Pharma Environment.
