Job Description

NPI Quality and Validation Engineer - Waterford

Ref No: AM18104

County Waterford, Republic of Ireland

Competitive salary

New Product Introduction Quality and Validation Engineer - County Waterford..

Job summary:

The Quality and Validation Engineer assists in the development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conform to established company, customer and regulatory requirements, supports New Product Introduction activities relating to Quality for products, processes or technologies, and for the enhancement or extension of existing product lines.

Key Responsibilities and End Results:

Provide technical support during the NPI process in ensuring that all FDA, QSR, MDR & EU GMP standards/guidelines are achieved and maintained in respect to device classifications.

Participation in the writing of User Requirement Specifications for new or changed Facilities (Cleanrooms), Automated Assembly Lines and Manufacturing Equipment.

Generating of Equipment Qualification Protocols and Reports and support the Engineering Team with its execution.

Cleanroom and Utilities validation protocols and reports (Execution and Review)

Generating Validation strategies, plans and protocols for NPI manufacturing processes in compliance and alignment to the Client specification and expectations, ensuring the process & product are operational ready post-Validation.

Support the transfer of ownership from NPI to Production phase, liaising with Programs Group and Operations Work Cells.

Conduct and Report Risk Management activities including conduction of End to End Process FMEA’s,

Generating Risk Management Plans and Risk Assessment Reports.

Support investigations and root cause analysis for issues identified during the NPI/Validation phase of projects.

Generating NPI Quality and Validation Deviations and CAPA required during the NPI and Validation stages of a project.

Metrology/Data Processing (Statistics), Process Capability calculations and correspondent reporting

Client Facing activities:

Aligning customer specifications to company capabilities.

Presentation of Quality and Validation Plans/Strategies to Clients during face to face/remote Project meetings.

Address Client Quality, Validation and Technical queries during the lifecycle of NPI projects during project meetings,

Provide Clients with Quality and Validation rationales that support both internal, Client and Regulatory requirements.

Represent NPI Quality and Validation in Client's Audits and/or Technical Visits and Regulatory Inspections.

Support the generation of DMF’s and other applicable regulatory documents where appropriate.

Ensure projects are prioritized in line with business needs.

Support NPI Quality and Validation Lead with on-going projects and new business developments and/or opportunities.

Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.

Support the external & internal Quality Management System auditing function.

Minimum requirements for this role:

Bachelor's degree required

At least 2 years' relevant experience. 

Preferably with knowledge/experience of manufacturing engineering, exposure to high volume automated assembly lines.

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