Quality Assurance Manager – Dexcom
Dexcom Corporation is a global leader in continuous glucose monitoring (CGM). We are expanding our European manufacturing site in Athenry and are looking for an experienced QA Manager.
Responsibilities
Develop, implement and maintain technical quality assurance and control systems.
Define and specify the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
Review engineering designs and contribute quality requirements and considerations.
Assist product support areas in gathering and analyzing data.
Supervise team in terms of costs, methods, and staffing.
Establish operational objectives and work plans for the Quality Department, delegating assignments and ensuring project deliverables are met.
Ensure the Quality Management System requirements are established and maintained at site and that internal policies, customer expectations and regulatory requirements are met.
Support complex, cross‑functional quality issues and drive resolution and proactive solutions to customer complaints.
Qualifications
Bachelor’s degree with 8–12 years of industry experience, or equivalent.
2–5 years of previous management or lead experience.
Medical device industry experience.
In‑depth knowledge of FDA 21 CFR 820 and ISO 13485 quality management systems.
Audit front‑room experience is an advantage.
Technical writing skills for manufacturing documentation and process development.
Hands‑on experience with high‑volume manufacturing and equipment development for assembly and automation systems.
Benefits
Front‑row seat to life‑changing CGM technology.
Comprehensive benefits program.
Growth opportunities on a global scale.
Career development through in‑house learning programs and tuition reimbursement.
Innovative, industry‑leading organization committed to employees, customers and communities.
Apply via the Dexcom Careers Site. Dexcom does not accept unsolicited resumes or applications from agencies.
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