Senior Quality Engineer

Work Flexibility: Onsite

**23-month fixed term contract**

Fully onsite in Carrigtwohill

Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.

•   Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

•   Work closely with operations and the business functions to ensure quality performance of product and processes.

•   Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities. 

•   Lead and participate in the development and improvement of the manufacturing processes for existing and new products. 

•   Analysis and review of concession requests.

•   Review and approval of change management activities.

•   Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary. 

•   Support execution and analysis of QATs.

•   Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

•   Proficient in risk management practices and tools, having high expertise in •   process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.

•   Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.

•   Proficiency in statistical methods and application.

•   Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise. 

•   Assist in the development, responsible for review & approval of process and equipment validation/qualification.

•   Support manufacturing transfers to other plants/facilities, leading quality activities.

•   Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.

•   Coach and mentor others in quality topics and activities.

Qualifications Knowledge Skills

•   Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline,

•    Previous experience in a regulated environment desirable.
•    CQE or equivalent course work / experience desirable
•    Proficient in understanding of Med Device manufacturing processes desirable.
•    Familiarity with ISO 13485, GDP, GMP desirable.
•    Lean Six Sigma training a distinct advantage. 
•    Excellent communication skills and attention to detail.
•    Have a good understanding of engineering and quality practices & methods.
•    High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
•    Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment. 
•    Must be willing to work as part of a multi-site team, with some travel required.
•    Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs. 
•    Highly developed problem solving and strong analytical skills. 
•    Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
•    Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes. 
•    Manages change well and adopts a continuous improvement orientation to the role
•    Excellent English (both oral and written)
•    Ability to be the voice of Quality when dealing cross functionally

Travel Percentage: 0%