Quality Assurance Specialist

3 weeks ago


Somerset, New Jersey, United States Demant Full time

Reporting to the Senior Director, Quality Assurance & Regulatory Affairs, the QMS Engineer will play a key role in managing the Quality Management System, Quality Engineering functions, internal and external audits, validation, and document control.

Primary areas of responsibility include CAPA, NCR, change control, risk management, process review and approval of QMS documents. Additional responsibilities include reporting on monthly/quarterly quality system metrics, training, and continuous quality improvements.

Responsible for ongoing adherence to external regulations as required by the Food and Drug Administration GMP, ISO 13485, 21 CFR 820, and other applicable regulations.

This position requires working on-site in our Somerset, NJ office 3 days a week.

Administration and Maintenance of the Quality Management System

Primary responsibilities include oversight of processes within the QMS, CAPA, effectiveness check, NCR, and managing electronic document control systems.

Supports and/or leads the investigation of quality issues. Investigate thoroughly using various root cause analysis techniques, document, implement corrective preventive actions, and perform effectiveness checks.

Maintains activities related to document change control processes, including oversight of controlled document lifecycles, document change requests, classification, release, training, and on-time periodic review.

Reviews all standard operating procedures (SOPs), forms, templates, reports, standard test methods, and specifications, and technical documents, as applicable, ensuring all documents are maintained to the latest revisions and format.

Supports the compilation of quality metrics for monthly trending, management review meetings, and follow-up for the closure of process improvements.

Presentation and communication of trending reports in respective quality forums.

Performs training for QA and stakeholders in QMS processes.

Identifies and implements process improvement projects to drive success in the areas of Quality Management Systems.

Cooperation and work with administrators of Quality Management System at Demant Holding.

Supervision of Documentation:

Review, approval, and process of QMS documents.

Administration of Mexico documentation web directories.

Maintain hard copy files of local documentation.

Create QMS and QA instructions and documents.

Conduct training of relevant Quality QMS documents.

Quality Reports and Daily Management Activities:

Create various quality reports for management and quality forum meetings.

Prepare data for the management review meeting.

Preparing the root cause analysis of quality KPIs.

Support logistics areas in terms of quality control aspects and solving problems processes.

Local Document Control:

Training.

Additional function - Internal Auditor of Quality Management System (QMS).

Bachelor's degree in science, engineering, or related discipline is required.

~3-5 years of relevant Quality Assurance experience required. Experience working in Medical Device Manufacturing company is preferred.

~Experience working with an electronic document management system.

~Experience in creating, reviewing, and processing documents, investigations, risk management, validation, and change controls.

~Working knowledge in the following fields:



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