Senior Quality Assurance Engineer

Senior Quality Assurance Engineer - Medical Device Manufacturing

Join to apply for the Senior Quality Assurance Engineer - Medical Device Manufacturing role at Dexcom

Senior Quality Assurance Engineer - Medical Device Manufacturing

Join to apply for the Senior Quality Assurance Engineer - Medical Device Manufacturing role 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.

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 Receiving Inspection Department within our Quality Assurance team are looking for a dynamic and skilled Senior Quality Assurance Engineer (Onsite role) to support the start-up of our first European manufacturing site in Athenry. As a member of the Receiving Inspection team, this engineer will liaise closely with R&D, Supplier Quality and Operations Engineering to ensure open and timely communication of pipeline project deliverables including but not limited to, material specifications, drawings, requirements, fixture design and development, Gage Repeatability & Reproducibility Studies, First Article Inspections, inspection procedures, inspection methods and sampling plans. You will also support the Supervision and Training of laboratory personnel.

Where You Come In

• You will work directly in the Receiving Inspection Department, evaluating inspection methods, process improvements, sampling plans, coordination of first article component and fixture inspections, selection and qualification of inspection equipment.
• You will work closely with, Quality Engineers and Supplier Quality Engineers to develop and implement inspection methods, sampling plans and related procedures.
• You will provide the primary input to the design, development and implementation of fixtures for measuring component parts in Receiving Inspection.
• You will develop inspection processes for complex and high-volume component throughput and design and develop methods to determine measurement accuracy and precision through testing and analysis.
• You will create and conduct measurement capability assessments (i.e. Gage Repeatability and Reproducibility).
• You will create test strategies and conduct process/equipment/measurement method qualifications and validations.
• You will be involved in planning, managing and prioritizing tasks/projects, tracking progress towards the overall goals and provide periodic updates to management.
• You will evaluate and determine cause for measurement variation and lead tasks associated with measurement variations.
• You will be responsible for OOS events, CAPAs, NCMRs and Change Order; establishing and maintaining communication to key stakeholders, reporting, investigation, disposition and the corrective action process.
  
  

What Makes You Successful

• Educational Requirements: 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.
• Proficiency with engineering software tools for CAD (SolidWorks preferred), engineering analysis, and statistical analysis (e.g. Minitab) and Microsoft Office Products is desirable.
• You will be proficient with basic statistical analysis (normality, standard deviation, variance, and comparison of data groups) including Gage R&R and test method validations.
• You will be proficient with geometric dimensioning and tolerancing and can read mechanical drawings
• You will be proficient in inspection equipment and fixture design, development and implementation.
• You have the ability to run self-directed projects, maintain timelines, transfer technology and execute projects in an R&D and GMP manufacturing environment.
• You can deal with ambiguity/uncertainty and a willingness to try new/challenging things.
• You can demonstrate strong interpersonal and teamwork skills and written and verbal communication skills.
  
  

What You'll Get

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community .
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organisation committed to our employees, customers, and the communities we serve.
  
  

Travel Required

• 0-5%
  
  

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.Seniority level

• Seniority levelNot Applicable

Employment type

• Employment typeFull-time

Job function

• Job functionEngineering and Information Technology
• IndustriesMedical Equipment Manufacturing

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