Quality Engineer 3

Quality Engineer 3

Quality Lead for all phases of product realization including NPD, NPI, Commercialization, Sustaining and End of Life. To bring creative, innovative and sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all Stakeholders. Quality oversight on problems of diverse scope including complaint & NC investigations, demonstrating good judgment in selecting methods and techniques for obtaining solutions, driving corrective actions & verifying effectiveness for assigned area. Oversee QA inspection, testing & release. Guides, supports and trains other quality team members

• Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area. • Trouble shooting quality issues identified during product development and commercialisation and driving solutions to reduce non-conformances. • Quality input and guidance on Validation planning and documentation utilising risk-based (pFMEA) decision making and driving risk mitigation activities into process development and product quality assurance. • Quality lead on vendor and part appraisal and approval processes. • Quality lead on process change and related assessment and implementation of change notification • Working with project team in the identification and implementation of appropriate statistical techniques and visual control systems to monitor the manufacturing processes. • Ensure that appropriate quality plans, test methods, test plans, deviations, work instructions, specification and drawings are in place and being adhered to during product development, manufacturing transfer and commercialisation. • Ability to understand and lead specification reviews, factoring in Teleflex capabilities, and drive alignment with customer on acceptance criteria ensuring Teleflex and Customer specifications/ drawings are aligned. Drive for reduction or elimination of variation from processes and inspections. • Ensuring that all design/specification /process changes are in line with customer contractual agreements and product safety while facilitating progressive and efficient change management. • Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule. • Establish and monitor process quality performance to determine when improvement actions are appropriate. • Key driver in responding to and acting on Customer quality feedback and requests. • QE review and sign off on QMS documentation and records • Participate or lead cross-functional project teams to eliminate waste and improve performance. • Develop and implement programmes to ensure compliance with regulatory requirements and documented controls and procedures within area of responsibility. • Provide support for Internal, Customer and regulatory audits. • Ensure full compliance with regulatory requirements. • Ensure Quality and EHS policies and procedures are adhered to at all times. • Projects as assigned

• Degree in an engineering/quality or related discipline • Certified QE desirable • Technical report writing • Process validations/FMEA's and protocols

• A seasoned, experienced professional with a full working knowledge of EN ISO 13485 the principles of GMP % FDA QSR 21 CFR Part 820 • Proficient in Statistical analysis • Structured Problem-Solving techniques – Lean Six sigma Green Belt desirable • Understanding of Lean Principles • Ability to drive projects to completion • Guided by the disciplines of due diligence and compliance in all aspects of work