Quality Management System Engineer

5 days ago

Somerset, United States Demant Full time
Job Summary

We are seeking a highly skilled Quality Management System Engineer to join our team at Demant. As a key member of our Quality Assurance department, you will play a critical role in ensuring the effectiveness of our Quality Management System.

Key Responsibilities
  • Manage the Quality Management System, including Quality Engineering functions, Internal & External audits, Validation, and Document Control.
  • Collaborate with internal QA team members and cross-functional departments to support QA activities.
  • Review and evaluate corrective/preventive actions (CAPA), including managing CAPA process, CAPA tool, effectiveness checks, and ensuring timely closure.
  • Support and/or lead the investigation of quality issues, using various root cause analysis techniques, and implement corrective/preventive actions.
  • Maintain activities related to Document Change Control process, including oversight of controlled document lifecycles, document change requests, classification, release, training, and periodic review.
  • Review all Standard Operating Procedures (SOPs), forms, templates, reports, standard test methods, and specifications, ensuring all documents are maintained to latest revisions and format.
  • Support the compilation of quality metrics for monthly trending, management review meetings, and follow-up for the closure of process improvements.
  • Perform training for QA and stakeholders in QMS processes.
  • Identify and implement process improvement projects to drive success in the areas of Quality Management Systems.
  • Manage Internal Audit function, manage list of auditors and competency, create yearly audit plan, audit schedule, and ensure audits are completed on time.
  • Coordinate and participate 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.
Requirements
  • Bachelor's degree in science, engineering, or related discipline.
  • Minimum of 3-5 years of relevant Quality Assurance experience.
  • 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, and 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.
What We Offer

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

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