Job Title
Quality Lead for Product Realization
The role is responsible for overseeing all phases of product realization including NPD, NPI, Commercialization, Sustaining, and End of Life. The individual will bring creative, innovative and sound Quality decision-making to the team.
Key Responsibilities:
* Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS.
* 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.
Requirements:
* A seasoned, experienced professional with a full working knowledge of EN ISO 13485 the principles of GMP & FDA QSR 21 CFR Part 820.
* Degree in an engineering/quality or related discipline.
* Certified QE desirable.
* Technical report writing.
* Process validations/FMEA's and protocols.
* 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.
Specialized Skills / Other Requirements:
* Ability to work in a fluid, demanding environment.
* Understanding and appreciation of ethics standards.
* Ability to gain technical understanding of processes and products.
* 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.
* Ability to understand key drivers of our manufacturing business.
Travel Required:
up to 10%.