Quality Assurance Engineer

Company: Drucker Diagnostics
Location: Philipsburg
Posted on: February 25, 2021

Job Description:

General Summary:This position supports all aspects of Quality in regards to the company processes, product designs, in-house manufacturing of components, and supplier quality in addition to ensuring corporate regulatory compliance to FDA CFR 820 and ISO 13485 standards.Design, install, and evaluate quality assurance systems and procedures to assure the highest level of product quality for the company; design or specify inspection and testing mechanisms and equipment; analyze production and service standards; recommend revision of specifications when indicated; formulate or help formulate quality assurance policies and procedures and assist in their implementation.Lead Quality investigations by troubleshooting component failures, nonconforming materials, and product failure either during manufacturing or after the sale. Work with suppliers to drive continuous improvement from approved suppliers, address non-conforming materials, drive incoming inspection activities to the supplier, and focus on reducing cost of Quality by reducing required Quality Control inspections.Provide input to Manufacturing Engineering to ensure manufacturing methods, systems, and processes produce the required level of quality. Implement workflow enhancements to improve plant wide production Quality thereby reducing cost and increasing profits. Develop, evaluate, and improve manufacturing methods with a focus on Quality by utilizing knowledge of product design, materials, fabrication processes, tooling, equipment capabilities and assembly methods.Provide input to Design Engineering to ensure product designs, design systems, and design processes produce the required level of quality.Keep abreast of industry standards related to corporate responsibility and compliance practices, as well as regulatory news that could affect the company's business activities regionally, nationally, or internationally.Essential Duties and Responsibilities:* Improve operational quality and reduce scrap, through incorporation of 5S and lean manufacturing practices* Analyze manufacturing process flows for the enhancements of quality, cost reduction, and throughput while maintaining quality* Conduct or supervise investigations to determine root cause of failure and participate in or make recommendations for corrective actions* Assist in design, layout, and installation of jigs, fixtures, and production equipment needed to improve quality.* Develop quality control test procedures, test criteria, and inspection techniques for supplier components and finished goods* Complete and properly document projects and implement systems procedures and policies to improve product quality and manufacturability leading to improved quality.* Participate in on-site quality system audits of critical or problematic suppliers* Conduct training on quality assurance concepts and tools to the organization* Assist in the development of forms and procedures for the quality system* Update and maintain job knowledge by participating in educational opportunities and reading professional publications* Assist in design and engineering of equipment, facility, and flow paths to optimize total quality* Provide regulatory expertise and support as required by the organizationSupervisory Responsibilities:* May oversee Quality Technicians or other Quality Assurance rolesQualifications:* Demonstrated leadership abilities and strong business acumen* Experience with Quality System Documentation and good manufacturing practices* Exceptional prioritization and organizational skills * Strong project management skills and robust research and reporting capabilities* Strong interpersonal skills: ability to work in a cross-functional, project team environment* Excellent writing, reading and documentation skills including record maintenance/ tracking and understanding of document traceability* Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities* A detail-oriented individual, with a "can do" attitude, and the ability to work in a team environment, as well as individually (with minimal supervision)* Quality Engineer Certification (CQE) from ASQ or equivalent is desired* Strong knowledge of ISO 13485 Quality Systems, FDA, EU Directives and general QSR concepts and guidelinesEducation and /or experience:* Bachelor's of Engineering or equivalent experience working in a laboratory or medical device manufacturing environment preferred. Experience in FDA regulated environmentsDesired:* Specific experience in applied manufacturing, design, and development of regulated products with a focus on quality or Regulatory Affairs field concerning medical devices* Experience as a compliance engineer focusing on safety, EMC, Radio, Energy Efficiency, international regulatory certifications, or a similar discipline with 3 or more years of laboratory or medical device experience* Experience with ISO and/or FDA compliance requirements* Lean manufacturing, 5S, and single piece (cellular) assembly experienceLanguage Skills:* Excellent written and verbal communication skills required to seamlessly work across groups at all levelsComputer skills:* Working knowledge of Microsoft Office Suite, particularly Excel and Word* Experience with ERP environments (specifically Epicor) a plus* Good statistical knowledge and application skills* Minitab experience a plusPhysical demands:* Ability to lift up to 50 poundsWork environment:* Office and Manufacturing EnvironmentTravel requirements:* InfrequentPowered by JazzHRarpRMx3m5e

Keywords: Drucker Diagnostics, Pittsburgh , Quality Assurance Engineer, Engineering , Philipsburg, Pennsylvania