Quality Engineer (Facilities Validation)

at  Dexcom

THE COMPANY

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we’re just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we’ve started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We’ve already changed millions of lives and we’re ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We’ll get there by constantly reinventing unique biosensing-technology experiences. Though we’ve come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Our Quality Assurance team are looking for a dynamic and skilled Quality Engineer to support the start-up of our first European manufacturing site in Athenry . As a Quality Engineer, you will play a key role in designing , implement ing and maintain ing quality assurance protocols and methods for processing materials into partially finished or finished products. You will also be r esponsible 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 p rovide technical guidance and support validation and revalidation activities for sterilization, manufacturing, and /or facilities validation.
• You will c ollect, organi se 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 appl y 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 l ead or participate in internal audits, supplier audits to ensure systems comply with requirements and are effective.
• You will p erform Equipment, Process, Software and Test Method Validations.
• Y ou 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 i mprove 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 r eview and create schematics and mechanical drawings.
• You will a ssume and perform other duties as assigned.

What makes you successful :

• Typically requires a Bachelor’s degree in a technical discipline, and a minimum of 2-5 years related experience or Master’s degree and 0-2 years’ equivalent 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 ).

What you’ll get :

• A front row seat to life changing CGM technology.
• A full and c omprehensive benefit s progra m .
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursemen t.
• A n exciting and innovative , industry - leading organization committed to our employees , customers , and the communities we serve .

TRAVEL REQUIRED:

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  To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications

Please refer the Job description for details