Location: Tinley Park, IL
Company: Harbor Manufacturing
required. Training is available. The candidate must also have the following skills: Must be able to create inspection documents, such as Balloon Drawings, and Control Plans. Read drawings, understanding of GD&T, profiles, true position, datums, etc. Create instructions and manage data using Microsoft Excel spreadsheets, Word, and Outlook Excellent problem-solving skills, highly analytical, use fact-based problem-solving methods with strong interpersonal team-building skills including the ability to communicate with all levels of the organization.
Education and Experience High school diploma or equivalent required, post-secondary training or trade school preferred. Minimum of 2 years GD&T experience required ISO Quality Management Systems experience preferred
Quality Assurance (QA) jobs involve ensuring that products or services meet specific standards and satisfy customer expectations. Professionals in this field focus on systematic processes and preventative measures during production or development to prevent mistakes and defects. QA roles typically require keen attention to detail, problem-solving skills, and knowledge of industry standards. They may encompass various tasks, such as developing quality assurance plans, conducting tests, and analyzing data to improve quality and reliability. QA jobs contribute significantly to a company's reputation by guaranteeing product consistency and safety.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
Quality Assurance (QA) jobs involve ensuring that products and services meet certain standards of quality before they reach the consumer. Those in QA roles are responsible for developing and implementing testing processes, inspecting products for defects and non-compliance, and analyzing quality data to drive improvements. A key characteristic of QA positions is the focus on preventing errors rather than just correcting them, which necessitates a proactive approach and attention to detail. Additionally, QA professionals often collaborate closely with production teams to foster a culture of quality throughout an organization.
process, recommend 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.
