Staff Quality Compliance Specialist at Dexcom

Athenry, Athenry-Oranmore Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

24 Mar, 26

Salary

0.0

Posted On

24 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management Systems, Regulatory Compliance, CAPA, Process Improvement, Internal Audits, Risk Assessments, Documentation, Change Management, Cross-Functional Collaboration, ISO 13485:2016, CFR Part 820, ISO 14971, CMDR, Project Management, Technical Competence, Creative Problem Solving

Industry

Medical Equipment Manufacturing

Description

The Staff Quality Compliance Specialist has wide-ranging experience and uses professional concepts and knowledge to resolve complex issues in creative and effective ways. Leads and supports the organization 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, as an expert in the field, they would recommend and lead appropriate changes at a site or global level. Coordinate 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. Networks with key contacts outside own area of expertise. Exercises considerable latitude in determining objectives and approaches to assignment. Determines methods and procedures on new assignments and may coordinate activities of other colleagues. 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 Lead: Lead as well as 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. Other Duties as Assigned: This job description reflects management's assignment of essential functions and does not restrict additional responsibilities that may be delegated. Works on complex issues where analysis of situations or data requires an in-depth evaluation. Work is reviewed upon completion for adequacy in meeting objectives. Networks with key contacts outside own area of expertise. Exercises considerable latitude in determining objectives and approaches to assignment. Determines methods and procedures on new assignments and may coordinate activities of other colleagues 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 8-12 years related experience or Master's degree and 6-8 years equivalent industry experience or a PhD and 2-6 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 specialization; 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 Possesses knowledge of advanced concepts, techniques, and standards. Viewed as expert in the field within the function.

Responsibilities

The Staff Quality Compliance Specialist leads and supports the organization in ensuring compliance with government regulations and internal policies. They perform evaluations of internal operations and recommend changes to enhance quality and regulatory compliance.