Quality Management System Engineer

1 week ago

Somerset, United States Oticon Full time
Job Summary

As a Quality Management System Engineer at Demant Group Services Operations, you will play a key role in managing the Quality Management System, Quality Engineering functions, internal and external audits, validation, and document control. Your primary responsibilities will include CAPA, NCR, change control, risk management, process review and approval of QMS documents, and reporting on monthly/quarterly quality system metrics. You will also be 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.

Key Responsibilities

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 system.
Collaborate with both internal QA team members and cross-functional departments to support QA activities.
Reviews and evaluates corrective/preventive actions (CAPA) including managing CAPA process, CAPA tool, effectiveness checks, and ensure timely closure. Responsible for communicating CAPA status to cross-functional departments and external partners.
Supports and/or leads the investigation of quality issues. Investigate thoroughly using various root cause analysis techniques, documents, implement corrective preventive actions, and perform effectiveness check.
Maintains activities related to document change control process, 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, as applicable, ensuring all documents are maintained to the latest revisions and format.
Supports 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. Collaboration with other departments in creating, implementing, and updating procedures.
Manage internal audit function, manage list of auditors and competency, create yearly audit plan, audit schedule, and ensure audits are completed on time. Review audit reports and provide support to internal auditors.
Coordination and participation in external notified body audits.
Ensure QMS records are kept as per the QMS procedure.
Review change control notification and ensure all actions are completed before closure.
Perform or participate in validation activity and keep validation records.

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 process.
System Administration

Local document control.
CAPA.
NCR.
Training.
Additional function - internal auditor of Quality Management System (QMS).

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