Senior QA Manager (Quality Systems)

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

Benefits offered by this job

Benefits program

Growth opportunities

Tuition reimbursement

Job summary

Dexcom Ireland is seeking a Senior QA Manager to lead the European manufacturing site quality program in Athenry. You will oversee the quality system, audits, CAPA, and document control to ensure compliance with FDA and ISO requirements.

You will bring 13+ years of industry experience and 5-8 years of leadership to drive continuous improvement across manufacturing processes and QA programs, partnering with cross-functional teams to deliver robust quality outcomes.

Qualifications

• 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.
• Experience with MDSAP/ISO13485/FDA21CFR820(QMSR).
• Experience handling Back/Front rooms in audits.
• Knowledge of Six Sigma, Lean manufacturing, sampling plans and other statistical modelling.
• Ability to develop systems and processes that improve product safety, increase conformance, and reduce costs.

Responsibilities

• Lead quality system compliance and document control.
• Manage audits and non-conformance related to product and processes.
• Lead management review for the site.
• Lead and manage audit readiness for the site.
• Coordinate cross-functional improvements and investigations.

Skills

QMS knowledge

Audit management

Statistical methods

Process improvement

People management

Education

Bachelor's degree in a technical discipline

Tools

Six Sigma

Lean manufacturing

Sampling plans

Statistical modelling

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.

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.

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%

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