NPD Quality Engineer

About the Company:Trelleborg Medical Solutions is seeking a NPD Quality Engineer to join their team. Responsible to plan and coordinate quality assurance activities for medical device manufacturing through the design and development phases including validation for new product development. Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the companys Quality System and applicable external requirements and standards, including FDA, ISO 13485, and/or other regulatory agencies as applicable to medical device manufacturing. Working with internal and external customers to support creative approaches and solutions to problems.Responsibilities:Quality Engineer Expectations:In conjunction with the NPD team, plan, develop and execute equipment, software, test method, and/or process validation strategyPerform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA)Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ)Review and evaluate specifications, drawings, quality agreements, customer documentation and other documents as necessary to support NPD projectsPlan, coordinate, and oversee Test Method Development and Validation activities, initiate inspection plans for new/revised productDevelop test methods or work with the Metrology team to recommend equipment, sampling plans, and measurement techniques for inspection specificationsPerform measurement system analysis (MSA) Gage 1, Gage Repeatability and Reproducibility (GRR), Bias and Linearity, Resolution and Stability studiesPerform statistical analysis of inspection data, process characterization, design of experiments (DOE) results, ANOVA, Capability AnalysisAuthor and execute Quality Plans for Quality Management Systems and Organizational Objectives projectsInitiate and perform root cause analysis, using statistical and capability analysis to solve problemsAdhere to the companys Quality System (QS), write, and approve QS documentsReview and ensure compliance with QMS of all validation documents and recordsSupport Engineering, Manufacturing, and Inspection personnel in design, methods, tooling, validations, and other areas related to the control of productCommunicate with customers on clarification of specifications, completing customer documents, complaints, process changes, and other projects as neededUnderstand regulatory requirements (e.g. ISO13485, 9001, 14971, FDA 21 CFR 820, ITAR)Provide periodic work direction and assistance to QA inspectors, QA technicians and Quality Engineering TechniciansSupport other quality activities as necessary such as customer complaint (CC) and RMA system per procedures, corrective and preventive actions (CAPA)Support internal and external auditsSenior Quality Engineer Expectations:Train company personnel as needed in areas such as the use of equipment, inspection methods, statistical methods, processes, and quality systemServe as project team leader on projects. Schedule project activities and strive to meet deadlinesProvide mentorship to other Quality Engineers and Technicians through experiences and education as opportunities ariseDevelop ideas and strategies to improve operational efficiency, add value, aid business performance, and work towards a culture of continuous improvementSuccessfully manage multiple projects simultaneouslyDrive best practices through the application of effective quality engineering principles and procedures across functionsAs a valued Trelleborg team member, you will enjoy:Greater opportunity for impactCompetitive compensationGenerous benefits package: Health, Dental, Vision, STD, LTD, Life, 401kPaid time offBonusQualifications:Required:4-year degree in quality, engineering, or any related field2+ years in a manufacturing environment in a technical support roleDesired:ASQ Certified Quality EngineerFormal Six Sigma Yellow/ Green belt trainingKnowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)Senior level: including all the above5+ years in a regulated manufacturing environmentKnowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)Competencies:Ability to read, write, speak and understand the English language (with a translator, if necessary)Ability to communicate clearly by conveying and receiving ideas, information and direction effectivelyAbility to demonstrate adequate job knowledge to deliver a world class performanceAbility to challenge oneself to consistently meet all goals and deadlinesWillingness to strive for excellence by producing work that is free of errors and mistakesDesire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriatelyCommitment to making improvements company wideDemonstrated competence using Microsoft Office, Project, Access and JMPComprehensive understanding of applicable Work Instructions, SOPs, and ISO standardsWorking knowledge of statistical methods associated with six sigma and quality controlAble to perform math functionsEffective project leaderExperience with lean manufacturing principles and their implementationGood hand/eye coordination and depth perceptionGood manual dexterityCorrectable normal reading distance visionTravel:Up to 25% across sitesSalary info:$78,000 and up based on experience

Created: 2025-03-08