Job Summary: 

• Collect, create and analyse user perception insights in regards to the quality of design and experience of a product category
• Create and present the user perception insights
• Evaluate design concepts against user perception insights and identify opportunities and risks that influence the perception of the design quality
• Create and present the design quality vision
• Set design quality subjective and objective targets
• Evaluate and analyse competitor product performance in design quality and report on concept competitiveness
• Advise, agree and/or challenge on all aspects of design quality including dimensional quality, material definition, surface design, user interaction execution etc
• Lead/support the resolution of design quality opportunities and risks
• Lead regular cross-team discussions on the project health for design quality
• Use digital evaluations as well as physical models to assess design quality performance of the concepts
• Review and assess production prototypes to identify early design quality opportunities and risks, supporting teams to find solutions
• Conduct design quality evaluations of production level builds and components
• Lead design quality performance reviews
• Validate and sign off on final SOP build
• Create design quality lessons learnt report and share learnings with the design and engineering teams

Skills on Resume: 

• User Insights Analysis (Hard Skills)  
• Presentation Skills (Soft Skills)  
• Risk Identification (Hard Skills)  
• Design Quality Vision (Soft Skills)  
• Target Setting (Hard Skills)  
• Competitor Analysis (Hard Skills)  
• Cross-Team Collaboration (Soft Skills)  
• Prototype Evaluation (Hard Skills)

Job Summary: 

• Lead Design Quality Engineering efforts on product sustainability of released products to the market.
• Review production specifications, when requested by manufacturing, to clarify requirements, establish practical inspection methodologies, and/or improve product requirements for the overall manufacturability of products with the support of Design Engineering and manufacturing facilities.
• Ensure Essential Design Ouputs remain under appropriate manufacturing process control throughout the product lifecycle.
• Perform root cause investigation as part of improving product quality/performance issues as a result of design failure modes steming from product design and/or manufacturing process.
• Provide active leadership in understanding and implementing regulations/standards from product release through product retirement, acting as a resource to other functional groups, within the product design change process
• Use metrics related to sustainability activities to influence and/or drive improvements to design processes and any other relevant quality management system.
• Lead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment.
• Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process.
• Provide direction on how to perform Test Method Validations, where appropriate, leads efforts to reduce test method bias ensuring a robust accept/reject process. 
• Training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results.
• Ensure that proper training and/or process changes are implanted to ensure that Design Changes are properly and consistently documented, and reviewed by approvers quality in ordet to be compliant with all applicable standards, regulations, and internal QMS requirements across the organization.
• Provide statistical techniques for appropriate product testing strategies in aligment to risk levels estimated from the Risk Management process.
• Support NCRs and CAPAs related to design and/or inspection/test methods.

Skills on Resume: 

• Design Quality Leadership (Soft Skills)  
• Manufacturability Review (Hard Skills)  
• Root Cause Analysis (Hard Skills)  
• Regulatory Compliance (Hard Skills)  
• Metrics-Driven Improvement (Soft Skills)  
• Risk Assessment (Hard Skills)  
• Verification & Validation (Hard Skills)  
• Training & Development (Soft Skills)

Job Summary: 

• Drive continuous improvement of Design Control and Risk Management processes
• Work analytically using statistical methods and process/design excellence tools to establish test plans as well as evaluate test data
• Coordinate and conduct design verification and validation activities as well as design / process failure mode effects
• Act as a leader in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
• Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations
• Identify, monitor and manage potential project risks by creating a risk plan
• Responsible for clear project scope definition and deliverables, milestones, timeline
• Work closely with various stakeholders and play an active role in the Design Control team
• Bring in technical know-how to improve internal development processes
• Ensure the compliance of internal product development processes
• Continuous support and coaching of development projects and project leaders
• Guarantee quality assurance throughout the development of a product period
• Act as a moderator of FMEA and Lessons Learned workshops

Skills on Resume: 

• Process Improvement (Hard Skills)  
• Statistical Analysis (Hard Skills)  
• Verification & Validation (Hard Skills)  
• Quality System Leadership (Soft Skills)  
• Project Management (Soft Skills)  
• Risk Planning (Hard Skills)  
• Stakeholder Collaboration (Soft Skills)  
• FMEA Facilitation (Soft Skills)

Job Summary: 

• Lead and participate in Risk Management (FMEA, Hazard Analysis), Design Verification, Design Reviews, and Cybersecurity activities.
• Develop risk management plans, requirement traceability matrices, and summary reports in collaboration with Bioinformatics team members.
• Be responsible for creation and maintenance of design history file documents.
• Ensure DHF content completion, integrity, and regulatory & standards compliance, collaboratively communicating & resolving gaps
• Provide direction on CAPA activities including scope and implementation plans.
• Support change control process through the creation of documentation, ensuring the adequacy of verification or validation to support the change, good documentation practices, and compliance with procedures.
• Support internal and external audits and inspections.
• Conduct investigations, initiate or process actions from quality system feedback information (records review, acceptance activities, non-conforming materials reports, corrective action reports, complaints, and audit reports) 

Skills on Resume:

• Risk Management (Hard Skills)  
• Design Verification (Hard Skills)  
• Documentation Compliance (Hard Skills)  
• CAPA Direction (Hard Skills)  
• Change Control Support (Soft Skills)  
• Audit Support (Soft Skills)  
• Investigative Skills (Soft Skills)  
• Collaboration & Communication (Soft Skills)

Job Summary: 

• Develop Quality Plans for new product development initiatives
• Lead the development of adequate inspection criteria. Identify the need for custom gauging for NuVasive and suppliers
• Review design prints for design for inspection feedback
• Support transfer of design to contract manufacturer, including the establishment of inspection plans both at NuVasive and at the supplier, reviewing process validations and analyzing measurement system analysis
• Evaluate product changes for qualification and validation requirements and assist in change implementations
• Support Design Control activities such as review of verification and validation test protocols and reports, contribute to risk management plan generation, review tolerance analysis, review product requirements documents, etc
• Participate in quality system improvements, procedure updates, and improve the quality and reliability of products
• Generate Non-Conformance reports and carry out the root cause investigation, containment of product, risk assessment and follow up action items with involvement from development, regulatory and supply chain

Skills on Resume: 

• Quality Planning (Hard Skills)  
• Inspection Criteria Development (Hard Skills)  
• Design Review (Soft Skills)  
• Process Validation (Hard Skills)  
• Change Implementation (Soft Skills)  
• Design Control Support (Hard Skills)  
• Quality System Improvement (Soft Skills)  
• Root Cause Analysis (Hard Skills)

Job Summary: 

• Assist in preparation for regulatory submissions, and present Design Control elements during internal and external audits.
• Leads the review of field complaints and feedback, assists in the analysis and the development of corrective actions, monitors and reports complaint trend analysis
• Partners with the Post Market Surveillance group and Clinical Evidence group in the support of PMSR and CER updates
• Maintain Risk Management Files for the site in compliance with procedures.
• Evaluate all post launch proposed design changes to determine impact on risk level, verification and/or validation testing.
• Support CAPA, Quality Hold, NCMR, and Health Hazard Evaluation processes 
• Lead continuous improvement activities including contributing to system level procedural requirements/updates 
• Works cross-functionally to influence key stakeholders and provides training, leadership and mentorship to teams and junior QEs

Skills on Resume: 

• Regulatory Preparation (Hard Skills)  
• Audit Presentation (Soft Skills)  
• Complaint Analysis (Hard Skills)  
• Risk Management (Hard Skills)  
• Post Market Support (Hard Skills)  
• CAPA Management (Hard Skills)  
• Cross-Functional Work (Soft Skills)  
• Leadership & Mentorship (Soft Skills)

Job Summary: 

• Supports on-market product to ensure delivery of safe and effective products to customers by ensuring product changes and other support activities comply with design control procedures and regulations, as well as the requirements of ISO, MDD/MDR, and QSR regulations and standards
• Risk management, product performance analysis on similar products, design verification / validation including software validation, design transfer to manufacturing, DHF tracking and completion, and product release authorization for distribution
• Identification of necessary inspection, test, and audit procedures
• Identification of needed reliability testing, identification, procurement, and maintenance of needed engineering test equipment and support of process/product validation
• Responsible for development and release of engineering design documentation.
• Support manufacturing operations and supplier quality and provide expertise in product requirements, risk management, test methods, and statistical analysis
• Work with outside labs and suppliers to communicate Smith & Nephew product / process requirements as well as assess capabilities of the outside lab / supplier
• Maintain inspection/testing to ensure that incoming, in-process, and finished products meet functional specifications and quality standards
• Ensure completeness, accuracy, and testability of product requirements 

Skills on Resume: 

• Project Management (Soft Skills)  
• Regulatory Compliance Knowledge (Hard Skills)  
• Risk Assessment and Management (Hard Skills)  
• Statistical Analysis (Hard Skills)  
• Quality Assurance (Hard Skills)  
• Communication Skills (Soft Skills)  
• Problem-Solving (Soft Skills)  
• Attention to Detail (Soft Skills)