Quality Assurance Manager at Dexcom

Athenry, Athenry-Oranmore Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

22 Jan, 26

Salary

0.0

Posted On

24 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Engineering, Technical Support, FDA Regulations, ISO 13485, People Management, Technical Writing, Manufacturing Documentation, Process Development, High-Volume Manufacturing, Equipment Development, Assembly Systems, Automation Systems, Data Analysis, Root Cause Analysis, Cross-Functional Collaboration

Industry

Medical Equipment Manufacturing

Description

Our Quality Assurance team are looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As Quality manager, you will provide technical support for the projects, functions, and strategic objectives of quality. You will also be responsible for various aspects of Quality Engineering, including the supervision of support personnel and/or administration of specific aspects of the quality system. Where you come in: You will develop, implement, and maintain technical quality assurance and control systems You will define and specify the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products You will review engineering designs and contribute quality requirements and considerations You will assist the product support areas in gathering and analyzing data You will supervise team in terms of costs, methods, and staffing You will establish operational objectives and work plans for the Quality Department and delegates assignments. Specifically, assuring team are meeting sustaining project deliverables, creating communication between cross-functional departments, participating in the process or product investigations, identifying potential root causes, and providing business solutions You will be responsible for ensuring the Quality Management System requirements are established and maintained at site and the internal policies, customer expectations, and regulatory requirements are met You will support complex, cross-functional quality issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints What makes you successful: You have a Bachelor of Science or Engineering degree with minimum 7 years of related industry experience and training; or equivalent combination of education and experience You have medical device industry experience You have knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems). Audit front room experience an advantage. You have previous experience in people management or leading a team You have technical writing skills as applied to manufacturing documentation and process development - you are experienced in creating and revising technical documentation You have hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems.

Responsibilities

The Quality Assurance Manager will develop, implement, and maintain technical quality assurance and control systems while supervising the quality team. They will ensure that the Quality Management System requirements are established and maintained, meeting internal policies, customer expectations, and regulatory requirements.