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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