Quality Engineer 2

Position Summary

Responsible for quality input, review and release during all phases of product realization including NPD, NPI, Commercialization, Sustaining and End of Life. To bring sound Quality decision making to the team, ensuring effective implementation of the required QMS documentation, and professional communication with all Stakeholders. Quality input 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. Supports and trains other quality team members

Principal Responsibilities

•    Quality support within the assigned project teams to ensure Customer and QMS requirements are implemented and fulfilled to required GMP standards.
•    Ability to understand, provide input and support 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. 
•    Ensure that specifications agreed with customers can be fulfilled, incorporate design for manufacturing principles and that Teleflex and Customer specifications and drawings are aligned.
•    Key driver in responding to and acting on Customer quality feedback and requests.
•    Trouble-shooting quality issues identified during product development and commercialisation using structured problem-solving techniques 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 support on vendor and part appraisal and approval processes.
•    Quality lead on process changes 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.
•    Generating, executing and/or reviewing of inspection plans & records, test methods, risk documents, validation protocols & reports, deviations, work instructions and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
•    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.
•    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.
•    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.
•    Ad hoc tasks and projects as assigned by management

Education / Experience Requirements

•    Experienced professional with a good working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 &
the principles of GMP.
•    Degree in an engineering/quality or related discipline
•    Certified QE desirable
•    Technical report writing
•    Process validations/FMEA's and protocols
•    Good understanding of 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

Specialized Skills / Other Requirements

People:
•    Clear verbal and written communication
•    Ability to lead meetings
•    Ability to work in a cross functional team
•    Self-driven and requires minimal supervision

Strategy
•    Ability to understand the key drivers of our manufacturing business
•    Understand the impact of their job on the key business drivers
•    Basic understanding of other department’s impact on the key drivers and how all departments fit together.

Customers and Vendors
•    Ability to understand customer/vendor relationships
•    Ability to generate appropriate relationships with customers and vendors
•    Ability to deal with difficult customer or vendor communications
•    Ability to influence customers/vendors where necessary

Teleflex Specific competencies
•    Ability to work in a fluid, demanding environment
•    Understanding and appreciation of Teleflex ethics standards
•    Ability to gain technical understanding of Teleflex processes and products

TRAVEL REQUIRED: 0%.

WORKING ENVIRONMENT:
☒ Office

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