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Quality Engineer

San Jose, California
Quality Engineer
DEPARTMENT:  Quality Assurance
To inspect, audit and/or release medical device assemblies and support other QA functions, including (but not limited to) equipment calibration and documentation control activities.  
•    Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for class I and class II medical devices 
•    Maintain and improve the quality system in accordance with FDA Quality System Regulations and ISO 13485 requirements
•    Perform, or assist in performing validation activities for the processes, facilities, manufacturing, and test equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures)
-     Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production
-     Review / approve various qualification / validation plan documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate with minimal supervision
•    Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
•    Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
•    Lead or assist in the resolution of quality issues related to non-conformance reports, Customer Complaints and CAPAs
•    Provide Quality support to production and engineering
•    Evaluate product changes for qualification and validation requirements and assist in change implementations
•    Compilation, review and approval of quality documents (Policies, Processes, Procedures, templates, formats etc.)
•    Develop and apply corporate level quality objectives and metrics 
•    Lead and project manage quality initiatives 
•    Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes utilizing engineering knowledge
•    Ensure process compliance through the design and development of comprehensive procedures including work instructions, flowcharts, forms, templates, checklists, and other product or process related documentation, for recording, evaluating, and reporting quality data
•    Develop and implement methods and procedures for disposition of discrepant material
•    Failure Analysis - Provide quality expertise post market release to the quality engineering support team to analyze the returned product
•    Understands root cause investigation process and able to initiate routine problem-solving investigations
•    The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues
•    Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations
-     Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions
-    Participate in the initiation, issuance, review, and approval of Supplier Corrective Action Reports (SCARs)
•    Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level
•    Participate in the planning, scheduling, execution, and reporting of supplier audits
•    Participate in component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups
•    Initiate, review, and approve Document Change Orders (DCOs)
•    Collaborate with Manufacturing Engineering on process improvement projects
•    Investigate customer complaints and document investigation findings
•    Participate in internal and third-party audits (FDA, Notified Body)
•    Participate in Material Review Board (MRB) meetings

•    BS/MS in an Engineering or Science-related discipline 

•    3 years minimum experience in a medical device manufacturing environment
•    Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
•    Experience with non-conformances, CAPA, and Risk Management is required

•    Working knowledge of regulations, standards and guidelines related to quality
•    Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel


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