Quality Assurance Engineer
12 hours ago
- Ensures, through global and local Product Development Process procedures and efforts, that product software are developed, tested and transferred according to established procedures that will assure that they meet all quality requirements.
- Responsible to assist in the maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations.
- Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.
- Quality Engineering Support for product software Design Control Process -Implement/facilitate product risk management planning as needed. Facilitate and participate in design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary.
- Contribute in the documentation of quality systems and programs in the areas of training, change management, validation, design controls, including product verification and validation, CAPA for relevant design issues, documentation control considerations, etc. to ensure compliance with FDA and regulatory requirements.
- Serve as contact for assigned program(s) and provide coaching / mentoring to project managers and/or product development team in regard to the product development process, design control (e.g. risk assessment), etc.
- Review and provide feedback on product documentation to support the product development process.
- Participate in technical or specialty design review(s) for product development or participate as QA representative in the change management process for product development.
- ssists in the development and execution of training programs (e.g. change control, risk analysis, Design Controls, etc.).
- Prepare for and and support regulatory and agency inspections/audits (ISO/MDSAP/etc.), investigations, and inquiries regarding the control and assessment of product design quality. Support corporate/internal design control audits.
- Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Support implementation of corrective actions and preventive measures.
- Function as QA subject matter expert for cross-functional development team related practices: facilitate risk management activities, provide guidance for strategy and content of requirements and specifications. Provide strategies and approvals for verification methodologies, configuration management, validation and regression testing approaches.
- 10+ years directly employed in R&D Quality Assurance of Medical Devices.
- Requires a minimum of ten years experience in a related industry regulated by FDA and/or ISO.
- Requires demonstrated competence in software development processes, and the selection and use of Quality Engineering tools, techniques, and processes.
- Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
- Requires effective written and oral communication skills to interact across all levels of the organization.
- Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
- One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
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