Job Summary: 

• Be accountable for all complete product validation processes. 
• Develop and initiate standards and methods for inspection, testing, and evaluation. 
• Establish programs to evaluate precision and accuracy of production equipment and testing, measurement, and analytical equipment and facilities). 
• Be accountable for Supplier processes, Production processes audits. 
• Proving quality requirements in control planning. 
• Facilitate FMEA and other risk evaluation. 
• Support facilitation of Readiness Check. 
• Manage Approbation process and continue improvement. 
• Support CQM to provide technical/quality-related service for customer claims. 
• Support SQM to conduct the supplier assessment and management.
• Understanding and application of statistical analysis and sampling plans
• Understanding and application of Design Control and Risk Management

Skills on Resume: 

• Product Validation (Hard Skills)
• Inspection and Testing Standards (Hard Skills)
• Precision and Accuracy Evaluation (Hard Skills)
• Supplier and Production Audits (Hard Skills)
• Quality Control Planning (Hard Skills)
• Risk Evaluation Facilitation (Soft Skills)
• Statistical Analysis (Hard Skills)
• Design Control Application (Hard Skills)

Job Summary: 

• Analyzing product and software requirements
• Analyzing and verifying medical device designs
• Tracking and updating defects
• Guiding and approving detailed manual and/or automated test procedures that evaluate medical device systems against documented requirements
• Guiding, writing, and/or executing test procedures on a web, client/server or mobile phone platform
• Maintaining and controlling test execution records
• Technical writing, including guidance and/or development of test reports
• Defining and/or guiding test strategies and high‐level concepts for testing hardware and software within Smith + Nephew
• Working with various types of medical-device and software projects
• Making risk-based decisions, balancing business and compliance issues
• Planing and managing assignments of different levels of scope, mentoring others
• Communicating project risks, design control status, etc. at all levels of the organization.

Skills on Resume: 

• Requirements Analysis (Hard Skills)
• Medical Device Verification (Hard Skills)
• Defect Tracking (Hard Skills)
• Test Procedure Development (Hard Skills)
• Test Strategy Definition (Hard Skills)
• Technical Writing (Hard Skills)
• Risk-Based Decision Making (Soft Skills)
• Communication and Mentorship (Soft Skills)

Job Summary: 

• Primary on-market quality assurance support for design control activities.
• Provide guidance and direction to a multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company business objectives and quality standards.
• Define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR’s and specific Design Control projects activities.
• Understanding of process, design and product/design verification/validation.
• Relate information to specification, product claims, and design.
• Uses clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use.
• Responsible for implementation of design control policies and procedures.
• Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and suppliers performance.
• Liaises with project and program team members on technical and quality matters.
• Provide and/or participate in Design Control training.
• Responsible for review and approval of elements of Design Control including but not limited to Planning, Device History File(s), Change Control, and associated and supporting documentation.
• Responsibilities for review and approval of DMF, DMR, MVP, and FMEA.
• Ensures that quality and compliance with site procedures are communicated 

Skills on Resume: 

• Quality Assurance Support (Hard Skills)
• Multidisciplinary Collaboration (Soft Skills)
• Documentation Management (Hard Skills)
• Product Verification & Validation (Hard Skills)
• Clinical Knowledge Application (Hard Skills)
• Design Control Implementation (Hard Skills)
• Training and Development (Soft Skills)
• Compliance Review (Hard Skills)

Job Summary: 

• Provides quality support on design changes to existing products and the entirety of moderately complex projects requiring familiarity with and understanding of the required design control documentation.
• Reviews product and process changes for qualification and validation requirements, and assists in change implementations
• Provides technical input on risk management and ensures successful implementation of the risk management program for both safety and security product elements, as applicable.
• Implements systems to ensure timely quality inspections for incoming materials, components or finished goods products, and performs inspections
• Conduct investigations on complaints or audit issues as quality system feedback is provided
• Supports the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification and validation, as well as sterilization and packaging validation
• Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products
• Updating the User requirements based on market/field applications feedback for new product
• Generating the Design input based on #1 and subsequently support the creation of Design Outputs 
• Evaluate Risk Management (per ISO 14971) on product risks align with #4 and process Risk.
• Overseeing the Design Test Matrix (Verification and Validation) generate protocols for V&V.
• Attend Design Reviews and provide input.
• Build Design History File based on 1-5.
• Coach / mentor other team members in the use of Design controls

Skills on Resume: 

• Design Change Support (Hard Skills)
• Risk Management (Hard Skills)
• Quality Inspection Implementation (Hard Skills)
• Complaint Investigation (Hard Skills)
• Quality System Development (Hard Skills)
• Market Feedback Analysis (Soft Skills)
• Design Verification & Validation (Hard Skills)
• Coaching and Mentoring (Soft Skills)

Job Summary: 

• Collaborate with cross-functional new product development teams (design engineers, manufacturing, suppliers, regulatory, marketing, clinicians, etc) to bring innovative products to market
• Lead design validation activities to ensure user needs have been met and product usability is ensured
• Manage risk management activities (per ISO14971) throughout the design and development process
• Identify Critical Quality Attributes, and develop effective steps to ensure they are controlled (through inspection, process selection, etc.)
• Perform human factors assessments and take steps to address usability concerns
• Visit clinical facilities and health care providers (HCP) to gather use data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices
• Help plan and monitor initial customer launch, reviewing feedback for product quality issues
• Propose, review and approve proposed changes to design control and software management policies and procedures that are a part of the Company's Quality Management System
• Participate as a peer with design and development engineers on complex technical topics to ensure design solutions are compliant with company procedures, adequately mitigate safety risks, and are likely to be acceptable to regulatory product reviewers (if applicable).
• Develop and implement risk acceptability criteria as a part of the Risk Management Process.
• Provide for ongoing review of design control activities to ensure that all procedures guiding the processes and outputs of these processes meet applicable regulations and standards.

Skills on Resume: 

• Cross-Functional Collaboration (Soft Skills)
• Design Validation (Hard Skills)
• Risk Management (Hard Skills)
• Quality Control (Hard Skills)
• Human Factors Analysis (Hard Skills)
• Clinical Data Gathering (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Problem Solving (Soft Skills)

Job Summary: 

• Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Design Reviews, and Design Transfer.
• Identify the opportunities for continuous improvement of the Quality Systems, including Design Controls, document generation, and design testing processes.
• Participate in team projects and assignments, facilitating or leading sub-teams 
• Provide guidance and decisions on product development and software product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
• Assess product regulations and standards impact to meet global requirements.
• Work closely with New Product Introduction teams to meet compliance requirements on schedule.
• Ensure all necessary compliance documentation is current and available upon request.
• Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.
• Assist in preparation and/or review documentation required for regulatory submissions.
• Provide leadership to sites to ensure global product compliance requirements are understood.
• Advise Divisional and Business Unit leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk.
• Oversee the operations of the Design Compliance group to ensure accurate results, adherence to Company procedures, and timely completion of projects.
• Interface with corporate partners regarding quality issues, audits, and special projects.
• Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
• Provides direction and guidance to other Design Compliance engineers 

Skills on Resume: 

• Design Controls (Hard Skills)
• Quality Systems Improvement (Hard Skills)
• Team Collaboration (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Documentation Management (Hard Skills)
• Leadership Abilities (Soft Skills)
• Compliance Awareness (Soft Skills)
• Project Management (Soft Skills)

Job Summary: 

• Review and evaluate Functional Safety, DFMEA (Design Failure Mode and Effects Analysis), Component Specs, and Designation Safety-Relevant (DS) needs and requirements of various low to medium complexity systems in conventional diesel, battery electric, and autonomous vehicle projects
• Be the Engineering Quality (EQ) point of contact for Change Management development activities
• Collaborate locally and globally, if applicable, to evaluate design quality gaps and lead engineers to meet an acceptable safety integrity level
• Lead and moderate Hazard Analysis and Risk Assessments (HARAs) and ensure global alignment when applicable for low to medium complexity systems and change management development activities
• Lead and ensure technical completeness of all Functional Safety work products: Item Definitions, Safety Plans, Risk Assessments, and Test Cases
• Manage Safety Plans to align with product flow and functions
• Propose and develop Safety Concepts and assemble/ensure completeness of Safety Cases
• Develop detailed safety requirements for features, systems, and components
• Work with Engineering and Purchasing teams to support and conduct conformity checks for the Supplier Component Requirement Specs process for low to medium complexity systems
• Moderate Design Failure Mode and Effects Analyses (DFMEAs) and Fault Tree Analyses (FTAs) for low to medium complexity systems
• Track action assignments and drive them to closure
• Interact with engineering customers and suppliers to develop robust requirements
• Support Engineering Quality reporting, KPIs, track concerns, and support updating internal training documents
• Ensure ISO 9001 Engineering documentation is current and reviewed regularly, and uploaded to the Business Management System (BMS)

Skills on Resume: 

• Functional Safety (Hard Skills)
• Change Management (Hard Skills)
• Team Collaboration (Soft Skills)
• Risk Assessment (Hard Skills)
• Documentation Management (Hard Skills)
• Leadership Skills (Soft Skills)
• Problem Solving (Soft Skills)
• ISO Compliance (Hard Skills)

Job Summary: 

• Contribute to the achievement of the quality objectives.
• Participating in Common Sensing's QMS audits.
• Execution and record generation of key QMS process,NCRs.
• Contribute to the creation of Management Review records.
• Contribute to the management of suppliers.
• Maintain company training documentation.
• Coordinate equipment calibration and maintain related records.
• Maintain the approved supplier list (ASL) and supplier files.
• Actively execute quality assurance in production
• Performing quality final lot release for the finished product before being released for distribution, including review of production data from a contract manufacturer.
• Support the investigation of technical problems and evaluate & implement solutions.
• Support developing and/ or updating component and supplier controls.
• Support developing and/ or updating critical to quality specifications, in-process tests/inspection, or final process specifications.
• Participate and contribute to the material review board.

Skills on Resume: 

• Quality Management Systems (Hard Skills)
• Audit Participation (Hard Skills)
• Documentation Management (Hard Skills)
• Supplier Management (Hard Skills)
• Equipment Calibration Coordination (Hard Skills)
• Problem-Solving (Soft Skills)
• Attention to Detail (Soft Skills)
• Collaboration and Teamwork (Soft Skills)