Senior Staff QE NPI

This permanent hybrid role in the Anngrove site serves within the NPI QE team of the GQO Quality Assurance organization and collaborates with Advanced Operations and Design Assurance to manage quality assurance activities across design transfer processes.

Responsibilities

• General
  • Foster and lead collaborative internal and external professional relationships across Design Divisions, Advanced Operations and GQO functions associated with design transfer activities.
  • Drive and lead effective communication with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest quality that meet the NPI project goals.
  • Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.
• Risk Management
  • Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production related processes (PFMEA).
  • Support the Risk Management File through risk Management Principles.
  • Responsible for evaluation of process risks, risk mitigation and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.
  • Ensure all Risk Management outputs comply with ISO14971.
  • Support Design team to complete CQA/CTQ identification and inputs to DFMEA.
• Inspection
  • Develop and implement lean inspection strategies and inspection plans through state of the art inspection methods and technologies.
  • Ensure inspections are repeatable, efficient, and scalable.
  • Lead continuous improvements of inspection methods and sampling plans with a focus on human error risk elimination.
  • Lead First Article Inspection strategies, both internally and externally, and approve First Article Inspections.
  • Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.
  • Develop Measurement System Analysis strategy and approve executed MSAs.
• Validation
  • Support the development, execution, and approval of validation strategies with the goal of highly capable processes that result in high yield and scalability.
  • Influence processes towards validation instead of manual verification where possible.
  • Defend validations as the Validation Specialist during audits and external reviews; may serve as validation representative for Valgenesis.
  • Support sterilisation validation activity as required.
• Process Excellence
  • Apply appropriate statistical techniques to develop robust, predictive quality systems that are transferable and maintainable in production environments.
  • Provide expertise for NCs and CAPAs related to new products.
  • Act as a subject matter expert and mentor in problem solving and root cause tools; may serve as NC Specialist.
  • Support Design for Manufacture and Assembly through process design, inspection optimisation, and application of state of the art technologies and tooling & fixture development.
  • Support process benchmarking by providing quality experience as a process input.
  • Promote human factor error prevention and provide expertise in science of human factor error risk identification and mitigation.
• Purchasing Controls
  • Create and influence supplier qualification strategy and approve supplier validations and Production Part Approval Process.
  • Ensure suppliers' quality systems can perform process characterisation and develop highly capable processes that are scalable and meet expectations.
  • Ensure strategic sourcing options to provide long term supplier stability.
  • Provide quality input to influence proper selection of suppliers.
  • Support implementation of supplier certification.
  • Support Supplier Quality to establish quality agreements with sites and suppliers as part of NPI projects.
• Design Transfer
  • Represent quality assurance during the DTAP process, ensuring product launches meet or exceed metric targets such as Right First Time, manufacturing loss, inspection costs per unit, and product escapes.
  • Provide subject matter expertise in design transfer processes and procedures, participating and interfacing in internal and external audits with regulatory representatives.
  • Represent NPI Quality Assurance at design reviews and ensure integrity of the process design through robust NPI quality deliverables.
  • Support device design into production specifications.
  • Lead efficient transfer of lessons learnt knowledge to quality engineering support and peers.
  • Provide expert quality process support post launch per DTAP agreement.
  • Support control of product through appropriate system containment to guard against product escape during pre released builds.

Qualifications

• Level 8 Degree in Engineering or Science
• 6 years experience in a quality or technical discipline
• Travel required: None