New Product Introduction Quality and Validation Engineer required by leading medical devices company based in Waterford City. Reporting to the Head of Quality, the Overall purpose of this role The New Product Introduction Quality and Validation Engineer:-
- Assists in 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 from a Healthcare/Medical Device/Medicinal Product perspective 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 Clients 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 & internally Quality Management System auditing function.
- Bachelor's degree required
- 2 years related experience; or equivalent combination of education and experience in Medical Device and/or Pharma Industry.
- Preferably with Knowledge/experience of manufacturing engineering, exposure to high volume medical device or pharma automated assembly lines.
- Excellent organization, communication, computer & presentation skills.
- Excellent initiative, decision making and be able to work in a core team environment.
- Excellent time management skills.
- Solution driven with emphasis on performance and results.