NPI Validation Engineer
As a member of the New Product Introduction Team, the NPI Validation Engineer plays a crucial role in ensuring the effective management of product introductions and change controls, aligning with the requirements of ISO 13485, MDD 93/42/EEC, and MDR 2017/745.
The NPI Validation Engineer's responsibilities include, but are not limited to:
- Ensuring that new product introductions and change controls comply with ISO 13485, MDD 93/42/EEC, and MDR 2017/745 regulations.
- Participating in new product introduction programs and ensuring their adherence to ISO 13485 standards. When necessary, generating Product Technical Files and associated studies as required by MDD 93/42/EEC and MDR 2017/745.
- Completing the Validation Programme, which involves performing Risk Analysis, creating a Validation Master Plan (VMP), conducting Qualification (IQ/OQ/PQ) as per procedure QAP and other related procedures.
- Preparing technical reports to support completed Validation Programmes.
- Reviewing and releasing batch paperwork to facilitate product release.
- Applying Quality Engineering tools like FMEA, FTA, Root Cause Analysis, and DOE in the development of new products or processes related to raw materials, services, and finished products.
- Providing support for NPI Quality, including handling deviations, non-conformances, performing root cause investigations, and contributing to CAPA writing and reviews.
- Adhering to plant safety and health & safety requirements, taking responsibility for ensuring the health and safety of oneself and others.
- Being aware of the potential environmental impacts associated with work and reporting non-conformance incidents.
- Contributing to energy conservation efforts (e.g., lighting, equipment, air conditioning) to enhance energy performance.
- Participating in continual improvement activities for OH&S, Environmental, and Energy Management systems by providing feedback/suggestions and reporting incidents promptly.
Skills and Experience:
- Excellent communication skills, capable of effectively engaging with individuals at all organizational levels.
- Ability to work collaboratively across different functions within the organization.
- Demonstrates high performance behavior and fosters a culture of engagement within the NPI Team.
- Proficient in project management of NPI & PD projects, utilizing appropriate methods and tools such as PMBOK and Agile PM Methods.
- Experienced in leading problem-solving and process improvement projects of medium to high complexity using Six Sigma methodologies.
- Proven expertise in Product and Process Validation.
- Experience in Grinding, Moulding, EDM, and/or Laser processes would be an advantage.
- Degree in Engineering/Manufacturing/Quality with emphasis on Devices/Biomedical.
- Ideally, 4-5 years of prior experience as a Quality/Validation Engineer in the Medical Device/Pharma Environment.
For further information on this role please contact Gavin Moran on 087 410 8620 or email@example.com
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