Senior QA Manager (Quality Systems)

Dexcom Ireland - Athenry; Athenry; On-site; EUR 109,000 - 141,000; Full time

Benefits offered by this job

Benefits program

Global growth opportunities

Career development programs

Job summary

Dexcom Ireland is seeking a Senior QA Manager to lead development and implementation of quality policies and programs at our European manufacturing site in Athenry. You will ensure systems comply with FDA and ISO quality system regulations and manage audits and non-conformances.

The role requires 13+ years in the industry with 5–8 years of people management, a technical bachelor’s degree, and deep experience in regulatory affairs, quality systems, and continuous improvement.

Qualifications

• Experience with MDSAP/ISO13485/FDA21CFR820 (QMSR).
• Managed back/front rooms in external/internal audits.
• Reviewed data on product defects, response plans, dispositions; drove improvements.
• Knowledge of Six Sigma, lean manufacturing, sampling plans, statistical modelling.
• Developed systems and processes to improve safety, conformance, efficiency, and cost.

Responsibilities

• Support Quality System Compliance projects and objectives (Audit/CAPA/NCMR/Internal Audit/Management Review).
• Serve as a tactical decision-maker for regulatory interactions and conformance to requirements.
• Lead the Quality Department's objectives, plan, and cross-functional communication.
• Oversee audits, non-conformances, and management review for the site.
• Provide quality guidance to other departments and drive process improvements.

Skills

QA management

Regulatory compliance

Six Sigma

Lean manufacturing

Data analysis

Auditing

Education

Bachelor's degree in technical discipline

Tools

FDA CFR knowledge

ISO13485

Job description

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.

Meet The Team

Are you seeking to demonstrate your expertise to give 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!

Our Quality Assurance team are looking for the right teammate to support our European manufacturing site in Athenry. As Senior QA Manager, you will manage the development and implementation of the organization’s quality policies and programs. You will also be responsible for ensuring systems comply with FDA and ISO quality system regulations.

Where You Come In

• The Senior QA Manager provides support for the projects, functions, and strategic objectives of Quality System Compliance (Audit/CAPA/NCMR/Internal Audit/Management Review) and the document control area.
• You are a strong tactical decision-maker, handles unforeseen issues as they relate to Dexcom’s compliance with regulations and conformance to required regulations.
• You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations and conformance to required regulations.
• You are responsible for the area operational management with a track record of working/supporting high volume manufacturing.
• You design and maintain the quality system according to written policies and procedures.
• You understand domestic and international Quality System Requirements and how they interact to be able to provide quality guidance 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.
• You establish operational objectives and work plans for the Quality Department and delegates assignments. Specifically, assuring your team are meeting sustaining & development project deliverables, creating communication between cross-functional departments, participating in process or product investigations, identifying potential root causes and providing business solutions.You exercise supervision in terms of costs, methods, and staffing.
• You lead the team that manages projects and non-conformance as it relates to the product and processes.
• Lead management review for the site.
• Lead and manage audit readiness for the site.

What Makes You Successful

• You bring experience in MDSAP/ISO13485/FDA21CFR820(QMSR).
• You have managed Back/Front rooms in external/internal audits.
• 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 modelling.
• You take the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.

Experience & Education

• Typically requires a bachelor's degree in a technical discipline with 13+ years of industry experience and 5–8 years of previous people management experience.

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 organization committed to our employees, customers, and the communities we serve.

Travel Required

• 5-15%

AI in Hiring Notice:

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].

The annualised base salary for this position is from €108,715.00 to €140,690.00 gross. Final offer will depend on your qualifications, competencies, and professional experience.

#DexcomIreland