8 jobs found

This position performs precision inspections on a variety of components, subassemblies and finished product using customer specifications, military specifications and industry standard specifics along with standard and special purpose measuring tools, instruments and equipment. The following duties and responsibilities will be delegated and defined by the Quality Manager or Corporate Quality Director. ESSENTIAL DUTIES AND RESPONSIBILITIES : Performs inspection activities, to assess conformance of products to the design as defined by engineering drawings, blueprints, schematics, quality specifications/quality plans Interprets engineering drawings, schematic diagrams, or formulas and confers with management or engineering staff to determine quality and reliability standards Inspects products, components, subassemblies, and/or systems to ensure conformance to requirements. Identifies nonconformingconditions that present existing or impending defective conditions at the system or subsystem level of assembly. Preparts inspection plans and checklists for inspection Records variable data of inspections into ERP Generate discrepancy notices and initiate Material Review Board actions Perform material movement transactios after completion of inspection process May specialize in receiving inspection, in-process inspection, process verification/auditing, final inspection and other area?s as assigned. Recognizes and takes action to correct apparent discrepancies in specifications and procedures Determines the method and process needed to measure blueprint conformance on parts according to tolerances and normal gauge practices Read, understand and interpret part and gauge GD&T and coordinate drawings / models as it applies to gauging and measurements Adheres to all quality and safety standards Supports other projects and performs duties as assigned Support, communicate, reinforce and defend the mission, values and culture of the organization May specialize in gage calibration process  and conduct calibration for all basic hand tools and gauges Coordination of the recall notification for all tool/gauges that are required for calibration with in the given month Repair gauges and inspection as required to maintain accuracy of operation Assist in design review of gauges Obtain quotes for externally calibrated equipment Coordinate shipment of gauges for external calibration Enter Purchase Requisitions for external calibrations Enter internal and external calibration data within calibration tracking software Performs detailed product testing utilizing approved procedures on all items that are submitted for NIST traceable calibration. Identifies units in need of repair and ensures they are segregated and deemed unusable Performs NIST traceable calibration/certification of products utilizing written procedures and calibration templates Manages all aspects of external calibration requirements and documentation Uses the Calibration database to record test data, generate certificates and track product calibration history. Maintains familiarity with current and new products as well as all calibration lab standards and test equipment. Performs periodic maintenance on calibration equipment as applicable Adheres to all quality and safety standards Supports other projects and performs duties as assigned     QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty and responsibility listed above satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION:  High school diploma or equivalent EXPERIENCE:  Two to five years related experience and/or training; or equivalent combination of education and experience; ability to read and interpret engineering drawings and wiring schematics; experience in the use of inspection equipment including but not limited to calipers, micrometers and height gages; experience in First Article and First Piece inspection process; knowledge of manufacturing, ISO 9001 Quality Management System; knowledge of ANSI Y 14.5 Geometric, Dimensioning & Tolerancing; good mechanical/technical skills and ability to read engineering drawings; GD&T proficiency is highly desirable; previous metrology experience. OTHER JOB RELATED KNOWLEDGE/SKILLS/ABILITIES: Knowledge and experience in Lean Manufacturing methods is highly desirable. Strong interpersonal and communication skills, including ability to work in a self-directed environment. Abilty to prioritize, multi-task and meet deadlines Ability to work a varied schedule, willing to work overtime when necessary Possesses strong interpersonal skills and the ability to work with employees and managers at all levels within the company Possesses strong computer skills with demonstrated proficiency in standard business software packages (e.g., Microsoft Office) Experience in ERP systems, SAP desired Equal Opportunity Employer of protected Veterans, disabled individuals or other individuals regardless of race, color, religion, national origin, gender, gender identity, age or sexual orientation

Quality Engineer- STERIS - Mentor, OH STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894. The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.  Position Summary  The Quality Engineer is responsible for developing, maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.  Duties  Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance. Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis. Initiate and/or participate in process and product corrective actions and problem-solving activities. Update/establish documented procedures as needed. Review collected data to perform statistical analysis and recommend process/product changes to improve quality. Monitor and report on performance metrics. Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques. Collaborate with other departments and facilities within the company on quality related issues. Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials. Perform quality system audits and provide guidance on corrective actions. Perform other duties as assigned. Education Requirements  Bachelor's Degree in Engineering or related technical field is required  Required Experience  2+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience OR 1+ years experience with applicable internship experience. 2+ years of experience with medical device or other regulated industries preferred. 2+ years of experience working in an ISO certified environment required. ASQ, QSR or familiarity with QSR/GMP regulations preferred. Competencies  Excellent problem-solving skills Focus on identification of potential issues and continuous improvement. Experience working on cross-functional teams and on own initiative. Demonstrated excellent organizational, oral and written communications skills. Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint. Experience with statistical analysis software and Visio preferred. #LI-KK1  Working Conditions  Typical Office Setting  The Quality Engineer is responsible for developing, maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

Project Manager- Steris - Mentor, OH STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894. The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.  Position Summary  Are you an organized, results-oriented, collaborator who knows how to prioritize projects to have maximum impact on both Customers and the organization? Join our team as a Project Manager who directs all phases of the project from cross-functional team inception to completion of a commercialized product and through it's launch. The PM organizes and leads cross-functional teams on multiple new product development and current product projects that may include, at varying complexity, the following: major new products; major and small line extensions; major redesigns; sourcing projects; and value improvement and business continuity projects. This is a highly collaborative role requiring daily coordination of activity between engineering, document control, field sales, supply chain, product management, finance, Customers and outside vendors.  Duties  Works closely with the engineering, sales organization, and product management teams to respond to Sales Special Quotes (SSQ) requests promptly. Seeks to meet Customer requirements while aligning with product line strategies and engineering limitations. With input, develops both the SSQ cost and determines the sell price. Coordinates Sales Special Orders (SSO) workflow among functions to ensure that engineering, item set-up, materials procurement, manufacturing and documentation are completed in time to meet SSO ship date commitments. Oversees the creation of product structures in STERIS MRP systems including MBM hierarchy and costing. Coordinates with finance to get items set up in ERP system. Oversees the creation/revision of all documentation associated with SSO such as operator manuals, mechanical diagrams, electrical schematics, equipment drawings, software program documentation, device history records and factory test protocols. Leads weekly cross functional meetings, tracks action items, owners, timing. Manages outside vendors hired to produce and/or modify equipment for Customers. Measures and reports on key group metrics: SSQ response time and conversion rate, SSO processing time and profitability, Customer satisfaction. Education Degree  Bachelor's Degree in Engineering General or Management Required Experience  Education And Work Experience-  Minimum 5 years experience working in engineered products and/or product development Bachelor's degree in an engineering discipline or a management degree with engineering work experience Skills and Competencies-  PMP Certification or training in project management is desirable. Capable of solving engineering problems through accurate interpretation of requirements and test results. Excellent customer service skills. Exceptional team player and cross-functional leader. Experience in software project leadership is required. Experience in working with stakeholders to refine and meet product requirements. Experience in coordinating with multiple functions including Manufacturing, Service, Sales, and engineering. Some knowledge of PLC-based control systems and communication protocols. Some exposure to gas/vapor generation and transport systems Strong Interpersonal skills #LI-KW1  Join our team as a Project Manager who directs all phases of the project from cross-functional team inception to completion of a commercialized product and through it's launch.