Meet the Team
Our Quality Assurance team is looking for a dynamic and skilled Quality Compliance Specialist II (onsite role) to support the start-up of our first European manufacturing site in Athenry.
The Quality Compliance Specialist II supports the organization in ensuring compliance with applicable government regulations, industry standards, and internal policies and procedures.
The role evaluates internal operations, product/process controls, communications, risk assessments, and maintains documentation related to quality and regulatory compliance.
The Specialist recommends and supports appropriate changes at a site or global level, supports internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies within the Dexcom QMS, and coordinates the preparation of document packages for regulatory submissions and audits.
Where you come in
Oversee the quality and compliance aspects of establishing and maintaining processes related to commercial product shipment and release from Dexcom Ireland and global distribution centres.
Support and maintain Quality Plans to ensure Dexcom's medical devices meet regulatory, customer, and internal quality requirements throughout the product lifecycle.
Own and manage change orders impacting the Quality Management System (QMS) and facilitate cross-functional collaboration across departments and sites to ensure changes are thoroughly assessed and effectively implemented.
Lead or support Corrective and Preventive Action (CAPA) investigations and drive process improvement initiatives related to the QMS, ensuring timely resolution and effectiveness verification.
Provide guidance and support in assessing changes to QMS documentation, ensuring compliance with applicable standards and regulations.
Lead or support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions.
Lead or support ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality.
Conduct internal audits and support external inspections by regulatory bodies and notified parties, ensuring audit findings are addressed and closed effectively and preparing quality system documentation and records.
Lead or support compliance-related training initiatives within the Quality Department, ensuring all personnel are trained to meet regulatory, GMP, and internal quality standards.
Define, monitor, and report on key quality metrics and performance indicators (e.g., CAPA closure rates, deviation trends, audit findings) as part of Management Review and internal metric review meetings.
Other duties as assigned, reflecting management's assignment of essential functions and allowing for additional responsibilities that may be delegated.
What makes you successful
Experience with Quality Management Systems, Audits, CAPA, Change Management, and Management Review.
Knowledgeable in ISO *****:****, CFR Part 820, ISO *****, CMDR, and other regulations applicable to Medical Devices.
Collaborative, able to work effectively with diverse functional groups, and capable of multitasking and adjusting to changes in priorities.
Demonstrated diligence for compliance, technical competence, and good judgment associated with each essential duty and responsibility.
Experience and Education Requirements
Typically requires a Bachelor's degree and a minimum of 2–5 years related experience, or a Master's degree and 2–5 years equivalent industry experience.
What You'll Get
A front-row seat to life-changing CGM technology and insight into our brave community of users.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to employees, customers, and the communities we serve.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time.
The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons.
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