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NPI engineer

  • Job reference: 930390
  • Location: Cork
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 10/03/2020

Orion Group Life Sciences have an exciting opportunity for a NPI Engineer for our client based in Cork. This is a permanent role.

Job Purpose

This position is responsible for assisting in or leading the implementation of projects associated with process development/manufacturing transfer and validation through development life cycle phases.

Participate in appropriate local and global projects in order to contribute to continuous improvement of the Quality system and facility. Participate in cross-functional quality and business process improvement and integrating lean and best practices within the QA organisation. Leading role in determining project scope, goal, and deliverables, identifies tasks, resources required and project plans with guidance from management. Proactive in identifying budget, risks and resources needed to implement project. Track project to completion and ensure compliance with key quality standards and regulations.

Main Responsibilities of the role

  • Represent Quality Engineering through all product design and development phases to help ensure product manufacturability, reliability and cost effectiveness
  • Define validation strategy according to existing procedures, standards, specifications, equipment, manufacturing process and existing validated products
  • Create documentation associated with Quality Engineering activities including quality plans, validation protocols and reports and update Quality System procedures. Create and provide validation documentation according standards and regulation for product registration
  • Develop V&V protocols, technical investigations plans, engineering reports and related procedures which ensure statistical validity, adequacy and compliance to regulatory and corporate requirements
  • Constantly monitor and report on progress of the project to all stakeholders, identifying risks and steps for mitigation. Eliminating issues or delays as appropriate
  • Ensure adherence to regulatory requirements: RDC, ISO and FDA
  • Interface with Suppliers for new processes, quality issues and process improvements
  • Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues
  • Support the investigation and documentation of Customer complaints, CAPAs, and NCEs

Desired Experience and Background of the successful candidate

  • Graduate with an engineering or a technical degree with relevant work experience in the medical devices sector
  • 5 years' medical device experience with at least 3 years in a quality discipline preferred
  • Minimum 3-5 years' experience in a manufacturing environment an advantage
  • Project management experience
  • Outstanding written and verbal communication skills, ability to influence and lead others
  • Analytical skills (qualitative and quantitative), problem solving and root cause analysis
  • Attention to detail and accuracy, excellent organizational and planning skills
  • Demonstrated ability to meet deadlines
  • Proficient in Quality Systems and current standards or regulations including QSR and ISO 13485:2016
  • Demonstrated proficiency with Microsoft Project, Word, Excel, and PowerPoint

#NPI #engineering #NPIEngineer #QA #Quality #FDA #projectmanagement #ISO #13485

For more information on this role, call John Kelleher on +353 (0) 86 606 4309 or email for a completely confidential chat about this role and other opportunities using the reference number: 930390

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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