Quality Engineer - Medical Device Development

Quality Engineer - Medical Device DevelopmentDescription -Applies developed subject matter knowledge to solve common and complex business issues within established guidelines and recommends appropriate alternatives. Works on problems of diverse complexity and scope. May act as a team or project leader providing direction to team activities and facilitates information validation and team decision making process. Exercises independent judgment within generally defined policies and practices to identify and select a solution. Ability to handle most unique situations. May seek advice in order to make decisions on complex business issues.Responsibilities: Designs and integrates quality requirements, processes, and practices into the development, design, manufacturing, and continuous improvement of products or solutions for a customer segment or business unit.Supports the development, manufacture and delivery of quality products on time, to meet the requirements of the business, customers, and regulationsParticipates as Quality representative on select product development teams which includes providing guidance for Market Specification, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Assessments, and Design Reviews.Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures and applicable ISO and FDA standards.Provides design control guidance and technical guidance on instrument, software, firmware or assay performance.Ensures required documentation is completed prior to new product launch, and coach product development teams to successful completion where necessary.Reviews reports, test data, and process results for assigned components and subsystems to identify trends and issues, perform root-cause analysis, and develop recommendations for resolution.Communicates product and process issue analysis to product stakeholders; collaborates with management, internal, and outsourced manufacturing and development partners to recommend and implement changes to product or process to reduce defects and improve quality.Participates in internal and external audits by regulatory agencies and notified bodyFollows Good Documentation Practices.Provides input into the development of and changes to controlled documents (e.g., SOPs, Specifications, Methods, Reports, etc.).May perform Non-Product Software Validation activities.May perform Process Validation activities.May perform Risk Management activities.May perform release of production batches after successful QC.May be the process owner for or participate in QC activities.May perform Nonconformances, and Corrective and Preventive Actions (CAPA).May perform V&V activities.Education and Experience Required: Bachelor's or Master's degree in relevant area or equivalent.Typically 4-6 years experienceKnowledge and Skills: Strong analytical, and problem solving skills.Ability to effectively communicate quality plans, proposals, and results, and negotiate options at management levels.Excellent written and verbal communication skills; mastery in English and local language.Job -EngineeringSchedule -Full timeShift -HP Standard, Shift  (Germany)Travel -NoRelocation -NoEEO Tagline - HP Inc. is EEO F/M/Protected Veteran/ Individual with Disabilities.