Senior Quality Assurance Manager (Quality Systems)

Dexcom is a pioneer and global leader in continuous glucose monitoring (CGM).

Senior QA Manager - European Manufacturing Site, Athenry

As Senior QA Manager, you will develop and implement the organization's quality policies and programs, ensuring compliance with FDA and ISO quality system regulations and supporting audit, CAPA, NCMR, internal audit, and management review activities.

Responsibilities

• Manage development and implementation of quality policies and programs.
• Ensure systems comply with FDA and ISO quality system regulations.
• Provide operational management for high volume manufacturing, including design and maintenance of the quality system according to written policies and procedures.
• Interpret and communicate domestic and international quality system requirements to other departments.
• Lead the team in managing projects and non conformance related to products and processes.
• Conduct management reviews and audit readiness activities for the site.
• Establish operational objectives, work plans, and delegate assignments.
• Ensure team meets sustaining and development project deliverables, coordinate cross functional communication, and participate in process or product investigations.
• Identify root causes of issues and implement business solutions.
• Supervise costs, methods, and staffing, and resolve unforeseen compliance issues.

Qualifications

• Bachelor's degree in a technical discipline.
• 13+ years of industry experience, including 5-8 years in people management.
• Experience in MDSAP, ISO 13485, FDA 21 CFR 820 (QMSR).
• Track record managing back room and front room activities in external and internal audits.
• Proficient in reviewing product defect data, response plans, and dispositions; capable of recommending and implementing improvements.
• Knowledge of Six Sigma, Lean manufacturing, sampling plans, and statistical modeling.
• Strong tactical decision maker with ability to influence stakeholders in sensitive situations.
• Excellent communication skills for interactions with senior management and executives.

Benefits & Travel

• Front row seat to life changing CGM technology.
• Full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to in house learning programs and tuition reimbursement.
• Travel required: 5-15%.

Travel to local and regional sites as required.