Job Summary: 

• Develop statistically-based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed 
• Supporting staff quality engineering initiatives
• Test method validation (TMV) and report writing
• Design validation, and Design verification
• Recognized as an expert in work group and across functions.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods techniques and evaluation criteria for obtaining results.
• Lead and coordinate, review and approve DHF documentation created by internal and external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.
• Outline compliance and testing, perform risk management, and ensure product development activities are in line with anticipated regulatory requirements

Skills on Resume: 

• Sampling Plan Development (Hard Skills)
• Quality Engineering Support (Soft Skills)
• Test Method Validation (Hard Skills)
• Design Validation and Verification (Hard Skills)
• Cross-functional Expertise (Soft Skills)
• Complex Problem Solving (Soft Skills)
• DHF Documentation Review (Hard Skills)
• Risk Management and Compliance (Hard Skills)

Job Summary: 

• Perform tests according to various protocol requirements
• Develop supplier quality specifications, sampling plans, and vendor qualification
• Responsible for FMEA, DFMEA, risk assessment, and risk management activities
• Develop and implement initial processes for product development and manufacturing
• Collaborate with regulatory to define relevant, measurable, valid product specifications
• Adhere to GMP, QSR, ISO, MDD, MDR, CMDCAS, and HIPPA quality system practices
• Establish and monitors product development quality plans and support manufacturing activities
• Ensure compliance with design controls, valid product specifications, develop product test methods
• Assist in defining and implementing design assurance controls throughout the product development life cycle
• Perform final release of products upon completion of design control system activities (e.g., phase review, design history file (DHF))
• Document pre-clinical testing reports (bench, animal, biocompatibility, sterilization, etc.) to ensure alignment with regulatory expectations
• Define activities (plans, protocols, test methods, risk analyses, FMEA, etc.) to ensure adherence to regulatory expectations, the established Quality System and any required international standards

Skills on Resume:

• Test Execution (Hard Skills)
• Supplier Quality Management (Hard Skills)
• FMEA and Risk Management (Hard Skills)
• Process Development (Hard Skills)
• Regulatory Collaboration (Soft Skills)
• Compliance with Standards (Hard Skills)
• Product Development Quality (Hard Skills)
• Design Control Compliance (Hard Skills)

Job Summary: 

• Contribute quality and compliance expertise and guidance to teams responsible for addressing specific quality issues.
• Establish effective review techniques, ensure audit compliance.
• Provide oversight and monitoring of all phases of design to ensure compliance and timely resolution. Support and lead FMEA/Risk Management processes and activities.
• Work with business process owners to devise appropriate metrics to improve product and process.
• Establish Quality Assurance process metrics. 
• Trend, analyze, and report on quality data, develop recommendations based on data analysis.
• Support best practices for problem solving, root cause analysis, and solution selection tools
• Is responsible for the achievement of the technical goal/commitment of a project
• Analyze project ideas regarding realization options, evaluate impact on running projects
• Detects common architectural and functional components in order to enable reuse and maintainability
• Cooperate and guide business partners/ suppliers on national/international level

Skills on Resume:

• Quality Expertise (Hard Skills)
• Audit Compliance (Hard Skills)
• Design Oversight (Hard Skills)
• Risk Management (Hard Skills)
• Process Metrics (Hard Skills)
• Data Analysis (Hard Skills)
• Problem Solving (Soft Skills)
• Partner Collaboration (Soft Skills)

Job Summary: 

• Carrying out all Design Assurance activities of assigned product(s)/product line(s) as per the global system engineering process
• Assure the quality of design implementations on system, subsystem and component level across the DXR portfolio.
• Support several areas of system engineering techniques in system and subsystem programs across all DXR sites to achieve high quality and reliability. 
• Support Defining and consistent improvement of quality and reliability engineering procedures for DXR.
• Support in creating, maintaining, and governing the usage of general design guides for DXR X-ray systems.
• Support the Design Assurance Leader / System Designer / Architects of the system / Sub-system programs in the conduct of design reviews.
• Ensure as Independent reviewer that development activities are in adherence to acceptable design principles.
• Assure adherence to the design control process for design activities.
• Establish processes to ensure findings, risks, recommendations and outcomes are clearly documented and communicated.
• Ensure proper requirements capturing, progression towards design, verification, validation and tractability during development cycle and life cycle management.
• Facilitate the identification and deployment of resources to investigate and resolve issues in a timely and effective manner.

Skills on Resume:

• Design Assurance (Hard Skills)
• System Engineering Techniques (Hard Skills)
• Quality and Reliability Assurance (Hard Skills)
• Design Guide Maintenance (Hard Skills)
• Design Review Support (Soft Skills)
• Independent Design Review (Hard Skills)
• Design Control Process Adherence (Hard Skills)
• Issue Resolution Facilitation (Soft Skills)

Job Summary: 

• Lead/Co-ordinate phase reviews to ensure design control compliance
• Manage/Co-ordinate/Lead the technical documentation requirements of the DHF
• Provide leadership and ownership of the risk management process
• Facilitate FMEA (or equivalent) for engineering control phases
• Support/lead the solving of complex issues through detailed research and analysis of internal/external information
• Prepare and implementation the DA strategy for design verification & validation activity
• Maintain and update control and development procedures to ensure continued compliance with external standards (e.g. ISO13485, 21 CFR 820)
• Provide 'Assurance' representation at all 3rd party audits
• Provide 'Assurance' support to all suppliers/contract manufacturers

Skills on Resume:

• Design Control Compliance (Hard Skills)
• Technical Documentation Management (Hard Skills)
• Risk Management Leadership (Hard Skills)
• FMEA Facilitation (Hard Skills)
• Problem Solving (Soft Skills)
• Design Verification and Validation Strategy (Hard Skills)
• Standards Compliance (Hard Skills)
• Audit Representation (Soft Skills)

Job Summary: 

• Responsible for Design Control initiatives to develop appropriate Design History File documents. 
• Review and approve new product documentation
• Collaborate with Project Management to optimize Design Control process and develop Sustaining Quality Engineering process.
• Review and approve Design Control documents and protocols.
• Serve as the Design Control expert to organization.
• Develop and deliver Design control training for organization.
• Support Risk Management activities and ensure compliance with standards and regulation
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
• Participate in continuous improvement of design control process and project management planning.

Skills on Resume: 

• Design Control Management (Hard Skills)
• Document Review and Approval (Hard Skills)
• Project Collaboration (Soft Skills)
• Design Control Expertise (Hard Skills)
• Training Development (Soft Skills)
• Risk Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Continuous Improvement (Soft Skills)

Job Summary: 

• Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
• Assist with major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems
• Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
• Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
• Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
• Support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
• Monitor and develop reliability improvements to existing & new designs
• Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
• Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP’s, QSR 21 CFR Part 820 and ISO 13485
• Evaluate quality data and prepare periodic reports to monitor trends.
• Generate, review and approve Engineering and Development Change Orders for Design Assurance

Skills on Resume:

• Technical Support (Hard Skills)
• Statistical Reliability (Hard Skills)
• Complex Problem Solving (Soft Skills)
• Quality Tools Adoption (Hard Skills)
• Risk Analysis (Hard Skills)
• Risk Management (Hard Skills)
• Post Market Surveillance (Hard Skills)
• Cross-functional Collaboration (Soft Skills)

Job Summary: 

• Assure records/files are initiated and maintained in all relevant documentation pertaining to Quality Assurance for the design life cycle.
• Perform Quality Audits to determine the effectiveness of the Quality Program for the design lifecycle, prepare audit reports and support implementation of updates/improvements 
• Perform supporting design transfer audits of customer provided designs and design history files for quality, process and design controls as appropriate for related design activities.
• Establish and maintain control over all complex design processes and testing during the design life cycle
• Plan and participate in design reviews to assure that designs assure product quality
• Plan and determine capability of design processes to meet quality requirements
• Establish process controls, surveillance and monitoring procedures to assure product quality
• Analyze reported audit results and coordinate corrective actions for ongoing quality improvement.
• Participate in the timely investigations, disposition and corrective actions to prevent recurrence of process non-conformance. Follow up for completion and measurement of effectiveness
• Plan and coordinate training and education of the design engineering team as it relates to design life cycle processes and overall quality of the design activities.
• Maintain state-of-the-art knowledge by keeping abreast of new regulatory, quality and design techniques and methods by contacts with other industries, current publications and advanced education and membership in professional societies/organizations

Skills on Resume:

• Documentation Management (Hard Skills)
• Quality Auditing (Hard Skills)
• Design Transfer Audits (Hard Skills)
• Process Control (Hard Skills)
• Design Review Participation (Soft Skills)
• Corrective Action Coordination (Hard Skills)
• Training and Education (Soft Skills)
• Regulatory Knowledge (Hard Skills)

Job Summary: 

• Coordinate and/or support customer led project related risk management activities.
• Coordinate and/or support resolution of regulatory questions and recommend actions required to ensure compliance with regulatory requirements.
• Assist with the establishment of quality controls over all design processes and testing during the design life cycle.
• Assist in supporting design transfer audits of customer provided designs and design history files for quality, process and design controls as appropriate for related design activities.
• Assist in supporting supplier audits as appropriate for intended use of supplier for quality, process and design controls.
• Support training and education of the design engineering team as it relates to design phases and processes and overall quality of design activities.
• Participate in ongoing education and training in regulatory and quality standards to stay ahead of changes in the various relevant standards and in industry.
• Responsible for the Quality of work to ensure BEI meets, or exceeds Customer Satisfaction.
• Evaluate capability of design processes to meet quality requirements
• Participate in design reviews to assure that designs meet requirements and to assure product quality.
• Meet and discuss problems relative to the design life cycle and regulatory compliance questions.

Skills on Resume:

• Risk Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Quality Control (Hard Skills)
• Design Transfer Audits (Hard Skills)
• Supplier Audits (Hard Skills)
• Team Training and Education (Soft Skills)
• Customer Satisfaction (Soft Skills)
• Design Review Participation (Soft Skills)

Job Summary: 

• Health monitoring defining critical end-to-end telemetry that currently do not have, and require to assess the quality or risk of the Service as a Solution SW
• Includes the monitoring and alerting for symptoms of predictive outages.
• Provide insight into aspects of the customer journey
• Develop currently missing criteria for critical aspects of robust resilient technology such as authentication, licensing etc
• Define KPIs around these customer journey elements.
• Integrate Business Units under a consistent framework for the Deployment and managed services assessment and Reporting process, heavily focused on IT and business operations.
• Establish elements of a Solution SW or SW as a Service Release Process that focuses on Customer Quality
• Provide guidance in the selection and requirements of Chef, Terraform, Kubernetes, Dynatrace or equivalent tools.

Skills on Resume:

• Health Monitoring (Hard Skills)
• Predictive Outage Detection (Hard Skills)
• Customer Journey Analysis (Soft Skills)
• KPI Development (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• SW Release Process Management (Hard Skills)
• Tool Selection Guidance (Hard Skills)
• IT and Business Operations Integration (Soft Skills)

Job Summary: 

• Drives the identification and proper collection of performance objectives, design requirements, measures and metrics. 
• Implements to meet these criteria in collaboration with Operations Engineering, Regulatory Affairs, and other cross-functional partners.
• Ensures DHF completeness
• Supports audits and compliance assessments of the Design History File (DHF) and other program files to ensure quality requirements are met and audit findings are appropriately addressed.
• Support Post Market Surveillance activities by serving as a technical resource for problem investigations to guide root cause analysis and corrective action development.
• Leads DAE activities to improve customer satisfaction and successful achievement of corporate and department quality objectives.
• Maintains an up‑to‑date knowledge in the areas of Quality Assurance, Design Controls, Risk Management, and Statistical Techniques including company products, policies, and procedures. 
• Acts as a subject matter expert on these topics within NPD teams.
• Escalates project issues to management level, as warranted.

Skills on Resume: 

• Performance Metrics Collection (Hard Skills)
• Collaboration (Soft Skills)
• Design History File (DHF) Management (Hard Skills)
• Audit Support (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Customer Satisfaction Improvement (Soft Skills)
• Quality Assurance Expertise (Hard Skills)
• Risk Management (Hard Skills)

Job Summary: 

• Works closely with product development engineering, clinical, marketing and regulatory to facilitate the successful planning and execution of NPD projects.
• Collaborates with product development to develop test methodologies required to complete analysis of device designs. 
• Contributes to test method validation activities. 
• Develops Design Verification/Validation test protocols, execution, and reports 
• Leads aging testing protocol development, execution, and reports 
• Leads product risk management activities for assigned projects including leading Design and Use Failure Mode and Effect Analysis (FMEA) and essential requirements analysis. 
• Supports and participates in development of process risk management efforts.
• Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
• Ensures that DAE project activities are completed for each product development phase. 
• Represent Quality function in Design and Phase reviews

Skills on Resume: 

• Project Management (Soft Skills)
• Test Method Development (Hard Skills)
• Design Verification/Validation (Hard Skills)
• Aging Testing Protocols (Hard Skills)
• Risk Management (Hard Skills)
• Collaboration (Soft Skills)
• Manufacturability Translation (Hard Skills)
• Quality Assurance (Hard Skills)

Job Summary: 

• Working as part of the Resiliency team, provides all design assurance deliverables required in the sustain process with moderate level of coaching
• Evaluation of the materials, properties and techniques used in production of Zebra's devices or solutions
• Advising design engineering on the selection, application and test of mechanical and /or electronic components and systems for the given changes to the product
• Recommending design or test methods and statistical process control procedures for achieving required levels of product reliability
• Determining reliability requirements of components and systems to achieve company, customer and any governmental agency reliability objectives
• Using statistical methods to design reliability and verification test plans
• Participate in creation and analysis of qualification test plans and results
• Creating and analyzing designed experiments to determine main effects of low complexity device sub-systems to improve designs
• Responsible for quality and reliability sub team activities to support the initiatives of the core development team, program manager or product line management deliverables
• Analyze and approve Engineering changes to production products
• Contributes to innovation efforts by participating actively in brainstorming activities and actively benchmarking externally with other organizations on best practices in design assurance
• Provides product qualification or reliability test support over the life-cycle of the product to support cost saving initiatives, end of life part requalifications, second source requalifications or critical design improvements due to field performance or customer escalations
• Mentor or oversee the work of level 1 or 2 DAE or Technician level team members
• Participate in special projects as a representative of the DAE team or support process improvement activities within the broader function

Skills on Resume: 

• Problem-Solving (Soft Skills)
• Material Evaluation (Hard Skills)
• Statistical Analysis (Hard Skills)
• Component and System Testing (Hard Skills)
• Reliability Engineering (Hard Skills)
• Collaboration (Soft Skills)
• Mentorship (Soft Skills)
• Process Improvement (Soft Skills)