Sr QA Engineer

Sr QA Engineer

Dexcom

Athenry, Ireland

Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!   

Our Quality Assurance team are looking for a dynamic and skilled Senior Quality Engineer to support the start-up of our first European manufacturing site in Athenry. As a Senior Quality Engineer, you will play a key role in designing, implementing and maintaining quality assurance protocols and methods for processing materials into partially finished or finished products. You will also be responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.

Where you come in:

• You will provide technical guidance and support validation and revalidation activities for all aspects of manufacturing.
• You will collect, organise and evaluate validation data, analyse the cause of failures and provide solutions.
• You will supervise and administer specific aspects of the quality system.

You will design and apply company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.  Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.

• You will lead or participate in internal audits/supplier audits to ensure systems comply with requirements and are effective.
• You will perform Equipment, Process, Software and Test Method Validations.
• You will apply risk management, validation, sample size, and external standards review and implementation activities.
• You will apply techniques like six sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.
• You will improve systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• You will assist with investigation and disposition of nonconforming materials with the Materials Review Board.
• You will review and create schematics and mechanical drawings.
• You will assume and perform other duties as assigned.

What makes you successful:

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
• You can read, write, and understand specifications as well as inspection criteria and can apply inspection criteria using appropriate and properly configured inspection tools. 
• You are proficient in Microsoft Office and database applications (e.g. Excel and MiniTab).

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