Quality Assurance Manager

Posted 4 Days Ago
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Athenry, Galway
Senior level
Healthtech • Biotech
The Role
The Quality Assurance Manager will develop and implement quality policies and programs, ensuring compliance with FDA and ISO regulations, manage cross-functional teams, and support projects and strategic objectives related to quality inspection and documentation.
Summary Generated by Built In

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.

Are you seeking to demonstrate your expertise to give to something significant and assist individuals in handling their health? Do you enjoy encouraging and handling relationships to gain a deeper understanding of the business's requirements, and then crafting and implementing solutions to fulfill those requirements? Do you wish to be part of a top-performing team committed to ethical practices? If yes, then we have an opportunity for you!

You will handle the development and implementation of the organization’s quality policies and programs, ensuring systems align with FDA and ISO quality system regulations.

Where you come in:

  • The Quality Assurance Manager provides support for the projects, functions, and strategic objectives of the Incoming Inspection, Lot Release, Compliance, and Document Control and Training areas.
  • You are a strong tactical decision-maker who handles unforeseen issues as they relate to Dexcom’s compliance with regulations and each supplier’s conformance to required regulations.
  • You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations and each supplier’s conformance to required regulations.
  • You exercise supervision in terms of costs, methods, and staffing.
  • You craft and maintain the quality system according to written policies and procedures.
  • You understand domestic and international Quality System Requirements and how they interact to provide mentorship to other departments and companies. Must have the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
  • Establish operational objectives and work plans for the Quality Department. Delegate assignments. Assure team meets project deliverables. Communicate between departments. Investigate processes or products. Identify root causes. Provide business solutions.
  • You apply quality feedback data from customers, consumers, and internal inputs to drive continual improvement activities needed to achieve department strategic goals.
  • Lead the team that handles projects and non-conformance as it relates to the product and processes.

What makes you successful:

  • You review data on product defects, product response plans, and product dispositions; recommend and implement improvements.
  • You have knowledge of techniques like Six Sigma, Lean Manufacturing, Sampling Plans, and other statistical modeling.
  • Develop systems and processes to improve product safety, consistency, and conformance, increase production efficiency, and reduce costs.
  • Typically requires a Bachelor’s degree with 8-12 years of industry experience
  • Requires a degree in a technical discipline
  • 2-5 years of previous management or lead experience

What you’ll get:

  • A front row seat to life-changing CGM technology.
  • 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 organization committed to our employees, customers, and the communities we serve.

Travel Required:

  • 10-15%

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.

The Company
Chatswood, New South Wales
7,214 Employees
On-site Workplace
Year Founded: 1999

What We Do

Dexcom Corporation 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 over 10,000 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

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