The Quality Engineer will support the Quality Management System (QMS) to ensure compliance to FDA Quality System Regulation, ISO 13485 and other relevant Quality System Standards. The Quality Engineer will also participate in product development teams to provide design control quality assurance support to medical device development and validation efforts.
Essential Duties and Responsibilities:
- Understand and ensure compliance to ISO 13485, 21 CFR Part 820 and Quality System requirements.
- Support audits performed by Notified Bodies and regulatory agencies as well as audits performed by customers.
- Perform/participate in audits of suppliers as required.
- Act as the quality interface for assigned customers and/or suppliers.
- Participate in the technical review of design input specifications and design documentation for new medical devices.
- Assist in the planning, development and execution of verification and validation protocols for testing of products under development.
- Conduct risk analysis for products under development and for active products as required by the customer.
- Create Quality Plans and Master Validation Plans in support of customer product implementation.
- Support existing product/process issues, including NCRs, MRB, root cause analysis, Deviations, customer complaints, failure investigations and corrective actions.
- Manage customer deliverables and quality documents to an approved/released state.
- Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as company may from time-to-time assign to the employee.
Minimum Required Education and Experience:
- Bachelor’s Degree in Engineering, Quality Assurance or related experience.
- 5+ years in medical device quality assurance.
- Working understanding of ISO 13485 and FDA regulations, including QMS requirements for Class I, II and III medical devices.
- In-depth understanding of ISO 14971 Risk Management.
Skills
- Proficient in using quality management software, statistical analysis tools and Microsoft Office Suite.
- Ability to conduct Root Cause Analysis using Fishbone Diagrams, 5 Whys or other analysis tools.
- Strong written and verbal communication skills.
- Take responsibility for task and time management.
Education and Experience:
- 5+ years in medical device quality assurance.
- ASQ Certification (e.g CQE, CQA)
Apply
Success!
Your application was successfully sent!