• Ensure adherence to the Risk Management Process including the development of the Risk Management Plan.
• Develop Quality Plans for new products.
• Work with Supplier Quality on Control plans, First Articles, PFMEAs, and process validations for new parts.
• Perform on-site auditing of suppliers, as appropriate.
• Review and approves all production release specifications and drawings. 
• Ensure Critical Quality characteristics, SPC dimensions, and inspection characteristics
• Coordinate with Quality Assurance and Manufacturing Engineering
• Provide technical assistance to Manufacturing, Quality, and Operations groups throughout the early production builds and launch. 
• Support the effort through documentation and training 
• Author and execute Quality Plans for Product Design and Development projects.
• Initiate and/or consult in the development and/or update of Risk Management FMEA and Hazard Analysis documentation in cooperation with cross-functional engineering teams per project requirements
• Develop and perform operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams per project requirements
• Develop and justify appropriate sampling plans with the characterization of test/inspection methods and acceptance criteria.
• Author, review and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
• Statistical analysis and data base searches.

Skills: Risk Management, Quality Planning, Supplier Quality Auditing, Production Specification Review, Cross-Functional Coordination, Documentation and Training, FMEA Development, Statistical Analysis

• Generate/approve/manage post market surveillance and risk management activities.
• Ensure compliance to product specific standards, cGMP, QSR, FDA, ISO, IEC, UL, EN, MDD, and EU MDR requirements. 
• Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
• Provide quality oversight and leadership for quality related issues
• Investigates, documents and leads corrective/preventive actions to assure these are managed effectively.
• Provide quality support to product support project teams as the quality engineering representative. 
• Work with a team to develop methods and procedures to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established. 
• Generate/approve/manage design verifications, design validations, sterilization validations, process validations, supplier qualifications, test methods, capability studies, and risk management documentation.
• Support Management Review, and internal and external audits/inspections.
• Assist in other responsibilities requested by management to ensure compliance

Skills: Post Market Surveillance, Regulatory Compliance, Quality Oversight, Corrective/Preventive Actions, Quality Engineering Support, Test Method Development, Design and Process Validation, Audit and Inspection Support

• Provide technical support for the appropriate determination and implementation of sustainable Design Outputs with emphasis on specifications setting. 
• Assembly drawings, components, and material specs, work instructions, guides for troubleshooting and technical support, packaging and labeling specs, manufacturing/production process specs
• Monitoring methods and performance (QC) specs, incoming inspection strategy and instructions.
• Ensure the necessary artifacts are planned during Design Planning and Design Change, validating that justifications are quality-sustainable for artifacts tailored out.
• Facilitate FMEA for purchased materials, actively participating in the creation process of new part numbers.
• Review and approve final design repository master file for quality compliance, stewarding the integrity of the original design during cost saving projects.
• Ensure appropriate design of experiments and reporting for Design Validation and Design Verification
• Provide support for planning and live assessment of Process Validation, including IQ, OQ, and PQ. 
• Support cost-saving initiatives.
• Identifies, executes, and supports Quality Management System opportunities for improvement, challenging the status quo to optimize processes.

Skills: Design Output Specification, Technical Documentation, Quality Control Monitoring, FMEA Facilitation, Design Validation and Verification, Process Validation, Cost-Saving Initiatives, Quality Management System Improvement

• Actively execute quality assurance in design development
• Support writing and/ or updating design and development plans for new products or design changes of existing products.
• Support writing and/or approving risk management documentation, such as risk management plans, risk analysis, FMEAs, risk management reports, etc.
• Support writing and/or approving test protocols and reports.
• Support writing and/ or approving test method validations such as Gauge R&R and Attribute Agreement Analysis.
• Support writing and/ or approving equipment qualification protocols and reports.
• Support executing validation and verification activities.
• Support creating and/ or maintaining Design History Files/ Design and Development Files, as well as Technical Files.
• Support reviewing and/ or approving design output documentation.
• Ensure that quality system requirements are effectively maintained in compliance with FDA 21 CFR Part 820 and ISO 13485:2016.
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
• Perform other acceptance activities, as required, in accordance with Common Sensing SOP-9.
• Actively participate in the interactions with the contract manufacturer and suppliers as it relates to Quality and provide support in the resolution of quality problems.

Skills: Quality Assurance, Risk Management Documentation, Test Protocols and Reports, Test Method Validation, Equipment Qualification, Design Verification and Validation, Regulatory Compliance, Supplier Quality Management

• Work with R&D, Marketing & Commercial teams on the full end-to-end product definition
• Participates in project teams to review and develop clear and concise user requirements, verification and validation studies, risk analysis, test plans, control plans and product specifications
• Work with R&D and GE on Technical Risk Analysis and/or FMEA during development and industrialization of new products focussing on the product performance, industrial performances when processing the product along with regulatory compliance.
• In association with GE identify and define critical to quality (CTQ) product characteristics
• Work with downstream partners on validations to ensure controls are in place to deliver customer and regulatory requirements
• Support the definition & control of process inputs including supplier & raw material controls, QA testing & process Control Plans
• Lead problem solving and C. I focus on reducing variation during the development & industrialization phases and as part of the hand-off to the pilot site
• Ensure that there is a formal hand-over of quality processes and deliverables to pilot sites & other sites processing products
• Support the continuous improvement of the New Product Development Process, e.g., the definition of the deliverables for hand-off between Stages while ensuring compliance with ISO 13485
• Prepare and present summary documents/presentations of the validation testing results for senior management. 
• Maintain records & documentation that support the One Quality validation process

Skills: Product Definition Collaboration, User Requirements Development, Risk Analysis and FMEA, Critical Quality Characteristics Identification, Process Validation, Supplier and Material Control, Problem Solving and Continuous Improvement, ISO 13485 Compliance

• Experience supporting the development and/or sustaining engineering associated 
• Leadership skills and ability to influence cross functional teams to drive work scope to compliant and successful completion.
• Self-starter, bias for action with ability to support projects through to completion. 
• Good organization skills.
• Cross technology and cross discipline collaboration skills
• Understanding of Electromechanical Engineering, Software Development and Diagnostic instrumentation technologies 
• Are willing to contribute to change and guide teams in design control practice. 
• Ability to guide change at all levels
• Have the ability to collate and analyze large amounts of data to aid decision making
• Have excellent oral communications, business writing skills and presentation skills
• Are Self-directing, goal oriented and able to prioritize workload in a dynamic environment
• Are a team player who can build strong and influential relationships with internal stakeholders and external partners

Qualifications: BS in Product Design and Development with 4 years of Experience

• Experience in a design or manufacturing engineering field
• Strong familiarity of ASME Y14.5 Geometric Dimensioning & Tolerancing
• Familiarity with AS9100 or ISO9000 Quality Management System and/or related quality systems and programs
• Knowledge of Design Control activities and best practices
• Ability to methodically reduce complex technical jargon into concise instructions
• Ability to earn trust, maintain positive and professional relationships, and contribute to a culture of inclusion
• Relevant experience in transitioning a product from development, through production to operations
• Relevant experience in AS9145, Advanced Product Quality Planning and Production Part Approval Process
• Experience creating actionable metrics meeting organizational goals
• Aerospace, space launch, or military or commercial aviation experience
• Experience in Quality performance metrics analysis

Qualifications: BA in Industrial Engineering with 3 years of Experience

• Need to be able to make sound decisions with attention to details
• Understanding the impact of regulatory requirements on Smith & Nephew’s products 
• Must be able to provide and implement solutions to quality problems
• Ability to plan and schedule multiple projects and tasks
• Effective written/oral communication skills
• Team player
• MS Office, MS Excel, and Statistical software proficiency
• Experience reviewing engineering with a high attention to detail

Qualifications: BS in Quality Engineering with 4 years of Experience

• Experience with a working knowledge of blueprint reading, statistical methods, problem solving, international quality standards, and continuous improvement tools
• Knowledge of electrical, mechanical and electronic devices and functional characteristics to aid in effective prevention, detection, disposition and root cause analysis
• Skills analytical problem solving 
• Understanding of the standards, implementation and certification process of Quality Management Systems such as AS/EN9100, ISO-9001, or any other industry-specific standard or regulation. 
• Understands the requirements of customer-specific Quality System certification programs. 
• 14 CFR Part 21 background 
• Experience leading projects with demonstrated success. 
• Ability to conceive, produce and deliver significant presentations to external customers and management.

Qualifications: BS in Biomedical Engineering with 2 years of Experience

• Experience in medical device manufacturing or pharmaceutical industries.
• Design Control Experience
• Membership in the American Society of Quality Control (ASQ) or Society of Reliability Engineers
• Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.
• Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. 
• Demonstrated skill in using test and measuring equipment. 
• Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada.
• Superior analytical and problem solving skills and statistical applications experience.
• Ability to be creativity in achieving objectives while assuring compliance to internal and external requirements.
• Proven organizational and leadership skills. 
• Ability to work under pressure in a fast paced environment.
• Excellent oral and written communication skills and ability to interact effectively with all levels in the organization.

Qualifications: BA in Mechanical Engineering with 5 years of Experience