Quality Management System Engineer

Overview: Reporting to the Senior Director, Quality Assurance & Regulatory Affairs, QMS Engineer will play key role in managing Quality Management System; Quality Engineering functions; Internal & 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 responsibility includes 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 being on site 3 days per week in our Somerset, NJ location.

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 & 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, and technical documents, as applicable, ensuring all documents are maintained to 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.

• Other assigned duties/projects, as needed, to support continuous quality improvements.

• 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).

• Bachelor's degree in science, engineering or related discipline is required.
• A minimum of 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 conducting internal audits and participation in external audits required.
• Experience in creating, reviewing & processing documents, investigations, risk management, validation and change controls.
• Working Knowledge in the following fields:

• ISO13485
• FDA 21 CFR 820
• Internal Audits
• External Audits
• Document Control Management

The Company is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.