improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files. MAJOR RESPONSIBILITIES: Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects
and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Responsible for building appropriate product documentation (e. g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups
and Suppliers to produce 510K submissions, letters to file, etc.
as required. Coordinate product testing with internal and external laboratories as required. Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). COVID-19 Vaccination Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19.
This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law. Education Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field. Work Experience At least 2 years of experience in the Quality or Engineering. Knowledge / Skills / Abilities Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects. Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations. Experience using MS Office Suite products (Word, Excel, Power Point, Outlook ). Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting) Working knowledge of government and industry quality assurance codes and standards (e.
g. 21 CFR 820, ISO13485). Position requires up to 15% travel. PREFERRED JOB REQUIREMENTS At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
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 Provides technical leadership in large projects supporting testing, fixtures development & building/testing prototypes.
Influences lab activities and acts as the technical expert in infection prevention product lines, primary lab safety contact and maintenance. Duties Execute tests and collect data using test equipment that measures temperature, electricity, light, flow, pressure, strain, force, distance, time, noise, weight etc. Assists in analyzing equipment failures and factory work stoppage problems. Design, Develop, Build, qualify test fixtures when needed. Maintain facility in a safe,
clean, and orderly manner always in compliance with OSHA VPP standards.
Fabricates, repairs, improves designs and constructs mechanical and electromechanical equipment. Maintains detailed and up to date test data in laboratory notebook and active test logs. Support Customer escalations, when needed. Support manufacturing ramp up, and design transfer during product development Assists engineers in determining test methods and test design Assumes complex project assignment responsibility Ability to operate, set up and program Data Acquisition Systems and associated software Supports highly visible business critical escalations from Customers / Operations when needed Required Experience1.
Two-year Associate Degree or equivalent, apprenticeship or comparable specialized study in mechanical and/or electrical engineering, beyond high school level.2. 10+ years experience in electrical/mechanical and mechanical assemblies3. Demonstrated technical leadership presence4. Travel to Customers and operations sites, including up to 20% internationally Skills1. Skilled in the set-up and operation of electrical and mechanical test equipment and measuring tools necessary. Must be able to use drill press, band saw, metal working tools role modeling excellent machine shop practices.2.
Able to operate test equipment that measures temperature, electricity, light, flow, pressure, strain, force, distance, time, noise and weight.3. Works from prints, sketches, written and verbal instructions and is capable of interpreting specifications.4. Demonstrated proficiency in reading and reviewing for accuracy wiring/electrical schematics, plumbing schematics and engineering drawings. 5. Design, assembly and troubleshooting of complex plumbing assemblies and systems necessary.6. Demonstrated ability to work effectively as an integral part of a team and independently as necessary.7.
Skilled in planning, organizing, and controlling assigned activities and group activities8. Proficient in computer use and applications and familiarity with Data Acquisition systems 9. Self-motivated10. Excellent communication skills11. Excellent problem-solving skills
