Senior QA Manager (Quality Systems)

Senior QA Manager (Quality Systems)

Dexcom

Athenry, Ireland

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.