Quality Systems Analyst

Overview:

The Quality System Analyst plays a pivotal role in ensuring the quality and compliance of the quality management system, overseeing the creation and maintenance of key quality metrics, data analytics, and quality business processes within our organization. This position supports the implementation and maintenance of electronic Quality Management Systems (eQMS) and the analysis of quality metrics to evaluate quality system performance. The analyst will collaborate closely with cross-functional teams, including IT, Quality Assurance, and Engineering, to support data integrity, software validation, and quality processes.

Responsibilities:

Develop and maintain quality system metrics related to manufacturing and quality performance (e.g. complaints, lot acceptance, employee training) create and maintain reports, support new analytics and reporting across the organization

Support the implementation and ongoing management of a compliant electronic Quality Management System (eQMS) and data analytics platform used in the organization.

Coordinate with IT and quality teams to ensure proper validation and documentation of software applications impacting product manufacturing and quality systems.

Ensure work is performed in compliance with regulatory standards (e.g., FDA, ISO 13485, 21 CFR Parts 820 and 11) and internal quality requirements.

Build dashboards and reports to monitor the effectiveness of the QMS.

Conduct risk assessments and root cause analysis for quality issues, and lead corrective and preventive actions (CAPA).

Provide training and support to staff on quality system requirements, data integrity principles, and software validation practices.

Define, collect, and analyze quality system metrics and data to evaluate the performance and effectiveness of the QMS, facilitating continuous improvement.

Stay updated on industry trends and best practices in quality management

Qualifications:

Bachelor’s degree in Engineering, Computer Science, or related field.

Minimum of 5 years of experience in quality assurance or quality systems management, preferably in the medical device industry, with specific experience in eQMS implementation and management.

Strong understanding of regulatory standards and quality systems related to medical devices, such as ISO 13485, FDA QSR, and EU MDR.

Experience with software validation, data integrity, and quality metrics analysis in a regulated environment.

Excellent analytical, problem-solving, and project management skills.

Effective communication and interpersonal skills, with the ability to work collaboratively in a cross-functional team environment.

Professional certification in quality assurance (e.g., CQA, RAC) or IT (e.g., ITIL, CompTIA) is a plus.

Experience in creating Power BI Dashboards and reports

Permanent