Sr Quality Compliance Specialist at Dexcom

Athenry, Athenry-Oranmore Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Audits, CAPA, Regulatory Compliance, Process Improvement, Change Management, Documentation, Training, Risk Assessments, Continuous Improvement, ISO 13485:2016, CFR Part 820, ISO 14971, CMDR, Collaboration, Quality Metrics

Industry

Medical Equipment Manufacturing

Description

The Senior Quality Compliance Specialist supports the organisation in ensuring compliance with applicable government regulations, industry standards, and internal policies/ procedures. Performs evaluation of internal operations, product/ process controls, communications, risk assessments and maintenance of documentation as related to quality and regulatory compliance. Consequently, they would recommend and lead appropriate changes at a site or global level. Coordinates the preparation of document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Change Management Leadership: Own and manage change orders impacting the Quality Management System (QMS). Facilitate cross-functional collaboration across departments and sites to ensure changes are thoroughly assessed and effectively implemented. CAPA and Process Improvement: Lead Corrective and Preventive Action (CAPA) investigations and drive process improvement initiatives related to the QMS. Ensure timely resolution and effectiveness verification. Quality Documentation: Provide guidance and support in assessing changes to QMS documentation, ensuring compliance with applicable standards and regulations. Regulatory Integration and Gap Assessments: Lead or support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions. Continuous Improvement Lead of QMS: Champion and Lead ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality. Audit and Inspection Readiness: Conduct internal audits and support external inspections by regulatory bodies and notified parties. Ensure audit findings are addressed and closed effectively. Prepare quality system documentation and records for internal and external audits/ inspections. Training: Lead and manage compliance-related training initiatives within the Quality Department, ensuring that all personnel are trained to meet regulatory, GMP, and internal quality standards. This role supports audit readiness, continuous improvement, and the development of a strong quality culture. Quality Metrics: 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: This job description reflects management's assignment of essential functions and does not restrict additional responsibilities that may be delegated. Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Networks with senior internal and external colleagues in own area of expertise. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. Typically requires a Bachelor's degree, and a minimum of 5-8 years related experience or Master's degree and 2-5 years equivalent industry experience or a PhD and 0-2 years' experience. Direct experience with Quality Management Systems, Audits, CAPA, Management Review Knowledgeable in ISO 13485:2016, CFR Part 820, ISO 14971, CMDR and other regulations applicable to Medical Devices. Collaborative, able to work effectively with diverse functional groups, able to multitask and adjust to change in priorities To perform this job successfully, an individual must value and demonstrate diligence for compliance, as well as demonstrate technical competence and good judgement associated with each essential duty and responsibility. A seasoned, experienced professional with a full understanding of area of specialisation; resolves a wide range of issues in creative ways. Demonstrates further technical development and a track record of project success Demonstrates an ability to coordinate multiple projects simultaneously Considered a specialist in the field within the function.

Responsibilities

The Senior Quality Compliance Specialist ensures compliance with government regulations and internal policies by evaluating operations and leading changes. They also coordinate regulatory submissions and manage quality documentation and training initiatives.