Location: Plainfield, IL
Company: Kuusakoski US
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
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 entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
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.
displays, touch technology and motion sensing to support a range of industries including Healthcare, Automotive and Military. With headquarters just outside of Chicago, and multiple state-of-the-art facilities around the world, Grayhill has the engineering expertise and vertical integration to deliver standard and customized solutions quickly and cost-effectively.
Are You Ready to Grow With Us? Summary: Performs quality functions within the components team and serves as liaison to customers, suppliers as well as the internal Corporate Quality team. Essential Duties and Responsibilities include the following. Other duties may be assigned. Work alongside the Grayhill quality department
in compliance with all Grayhill quality requirements and processes, ensuring that product group activities meets or exceeds both the internal corporate quality requirements and the customer quality requirements.
Manage the key customer warranty claim systems with timely responses. Analyze warranty claim data and report on opportunities for improvement to the business unit. Prepare reports to communicate involvement and results of quality assurance activities. Lead the product groups' CCA process with timely and appropriate actions using 8D methodologies. Analyze CCA data and report on opportunities for improvement to the business unit. Lead the audit inspection of Component Division Production
Orders and Toolroom piece parts. Manage military A&B testing requirement process.
Manage special customer testing and review customer prints pertaining to testing. Coordinate efforts with Corporate Quality Lab. Maintain quality records for customer review and supply special Certificate of Conformance and/or testing results as required. Coordinate special customer testing with Corporate Quality Lab and Planners. Manage the Internal Corrective Action Request (ICA) process: initiate; review; contain; notify; analyze and implement customer corrective action. Serve as an internal auditor, auditing facilities as required. When required, obtain from Sales customer First Article requirements.
Review, interpret and ensure requirements are understood and met. Maintain records and have available for customer review. Design and implement quality training programs for Plant. Review, implement and maintain ISO standards as related to training and production quality. Participate in monthly quality meetings and in internal audits as assigned. Education and Experience: Bachelor's degree (B. S. ) Minimum of two years of applicable experience; or equivalent combination of education and experience Preferred Skills/Experience: Excellent communication skills with the ability to effectively work with all levels within the organization Strong intrapersonal skills - ability to thrive in a team oriented, creative, and collaborative environment.
Hands on experience working in manufacturing preferred. Experience with manufacturing process such as plastic injection molding, rubber molding, machining, or assembly. Experience working with customers and/or suppliers What we have to offer: You will be at the forefront of challenging work. We solve complex problems with innovative solutions across all teams and in all roles. There is purpose in our work! Comprehensive Health Insurance; medical, dental, prescription, and vision starting on day one.
Generous Paid Time Off 401(K) match up to 4% of salary Hybrid work model allowing 4 days a month remote Collaboration Space featuring ping pong, foosball, board games, and more. Company paid holidays Optional gap insurance coverages Company paid disability and basic group life 24/7 Employee Assistance Program Catered company events - to pause and celebrate the wins! We value diversity and inclusion. We are an equal opportunity employer and we do not discriminate on the basis of gender, color, race, religion, marital status, interactionual orientation, or national origin. Job Posted by Applicant Pro
