Precision Edge Surgical Products Company LLC
As a part of the global industrial organization Marmon Holdings-which is backed by Berkshire Hathaway-you'll be doing things that matter, leading at every level, and winning a better way. We're committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone's empowered to be their best.
Quality Engineer must have very good attention to detail and full understanding of the manufacturing processes. Must have previous experience with using multiple pieces of measuring equipment. Experience working with internal and external customers is a must, and following proper documentation processes is essential in this role.
FLSA Status
Reports To
Manufacturing and Quality Engineering Manager, Quality Manager, or Quality Engineer IIIEducation / Experience
BS in Engineering required3 years experience in quality engineering preferredEssential Functions, Knowledge and Competencies
6 sigma, SPC preferredAbility to lift 50 poundsUnderstand PFMEA's and Control PlansWorking knowledge of Validation activitiesDesign and Analysis of ExperimentsKnowledge of Lean ManufacturingKnowledge of Measurement System Analysis (Gage R & R)Process and Performance Capability AnalysisMust possess excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliersMust possess organizational, analytical, planning and supervisory skillsKnowledge of ISO 13485 and / or ISO-9001 International Quality System StandardsKnowledge of the FDA's QSR 21CFR part 820 Medical Device StandardResponsibility / Authority
Participate in Material Review Board (MRB)Participate in New Product Release Review (NPR)Create inspection plans for new and existing productProvide Quality support through manufacturing processFacilitate Corrective and Preventative ActionsFacilitate Validation activitiesCreate and maintain PFMEA's and Control PlansUnderstand and Implement Customer Specific RequirementsFacilitate Customer AuditsProgram inspection equipmentWrite / Up-date Work InstructionsUse statistical tools to analyze data, make recommendations and improve process capability.Develop, implement and maintain a Statistical Process Control programPerform special projects and assignments as defined by the Quality ManagerEvaluate and improve inspection systems / procedures. Design and implement new inspection methods and improve current inspection methodologyWork with customers and suppliers to standardize inspection methodsPerform process capability analysis and recommend improvementsPerform Gage R&R studies and recommend improvementsPerform Vendor AuditsSupplier QualityTrain employees as neededSupervisory Responsibilities
NoneFollowing receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.
We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.
