Staff Quality Engineer - Product Development

Staff Quality Engineer - Combination Products Join to apply for the Staff Quality Engineer - Combination Products role at BDThis position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform.Job Responsibilities Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.The ability to create, support, review chemistry, manufacturing, and controls device submissionsParticipates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completedLeads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)Leads component qualifications, design validation, design verification, drug stability and process validationLeads product investigationsAbility to make and present risk‑based decisionsAssess product changes against product designSupports translation of design inputs into manufacturing control plansDevelop and implement procedures to comply with corporate and industry standards.Coordinates and/or directs all aspects of product development activity related to a product lineLeads development of risk assessments and test methodsQuality engineering representation on Product Development and Design Review teamsPrepare and present project updates and technical discussionsParticipate in project planning, budgeting, scheduling, and trackingSupport internal and external supplier auditsProvide support to the regulatory department in writing technical submissionsComplies with company procedures and policies, government regulationsActively participates in training and providing input to training of employees on division procedures and policiesAbility to travel for business, project, and issues approximately up to 25% of time.Other duties and projects, as assignedEducation And Experience BS in Engineering, biological science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or BiochemistryMinimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industryPharmaceutical or combination product experience preferredRequired Qualifications Knows how products are used and impact the user(s) so that risk can be managed effectivelyApply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Ability to lead creation of risk management filesAbility to develop solutions with business impactAdvanced statistical and risk assessment techniquesWorking knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologiesAbility to make and present risk‑based decisionsStrong interpersonal skillsAbility to analyze and optimize manufacturing and quality systemsProduct, design & prototypingAbility to create and provide trainingProblem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to lead cross functional teamsUnderstanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH GuidelinesPreferred Qualifications Quality Engineering Certification (ASQ) or equivalentPhysical Demands While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.Work Environment While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team‑oriented, fast‑paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.Travel required 25%#J-18808-Ljbffr