Location: Wheeling, IL
Quality Assurance (QA) Jobs encompass roles focused on ensuring that products or services meet established standards of quality, reliability, and performance. These positions typically involve identifying defects, designing test procedures, conducting tests, and making improvements. Key characteristics of QA jobs include attention to detail, a strong understanding of quality metrics, the ability to analyze data, and problem-solving skills. Individuals in QA roles work closely with development teams and are critical in maintaining customer satisfaction by preventing errors and enhancing the user experience.
process and test method validation within Design Control and Software Development Life Cycle {SDLC). Reviews and approves software lifecycle deliverables. Directly influences project direction and scope, guides product development teams through design validation and regulatory compliance and assures robust product vs.
customer requirements. Applies established quality and engineering methods to the investigation and solution of software quality problems. Supports CAPA {Corrective Action Preventive Action) and FCA (Field Corrective Action) activities as required. Participates, through the creation and review of improvements of software development, software processes, and documentation
processes. Supports supplier qualification and maintenance activities. Performs SCAR {Supplier Corrective Action), and process deviation activities. Participate in internal and external (i.
e. FDA, Registrar, Notified Bodies) audits. Understands and backsses the impact of a change on the safety and efficacy of a software product, device, process performance, and internal/external customer expectations worldwide. Participates in Risk Management activities. backsses internal and external risks associated with specific actions, quantifies risks, seeks input from others, and identifies actions to limit the exposure of the division. Supports and provides oversight to non-product software lifecycle
activities including review and backssment of software activities {suppler evaluations, validation, lifecycle deliverable documents) to ensure compliance with applicable procedures, standards, and regulatory requirements.
Participates in multi-site and business wide software lifecycle activities to accomplish quality system objectives. Investigates and analyzes impact of failure within and across product lines. Uses technical, compliance, product, and process knowledge to assist in identifying preventative actions. Able to assure effectiveness of actions are taken to prevent reoccurrence. Requirements: 4-year degree (Bachelor? s Degree) in a scientific or technical discipline preferred or 10+ years of experience in a related field.
1-3 years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes. Excellent communication skills, problem solving capability and attention to detail is critical. Knowledge of regulations and standards affecting software development and overall design control for medical devices. Experience in applying quality regulations and standards {e. g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, Cybersecurity- ISO 27001), and working knowledge of current and applicable GMP regulations is required.
Use of analytical skills and ability to organize work in a logical and thorough manner. Capable of analyzing data to support the development of strategies to effectively manage, enhance, mitigate, and/or resolve potential issues. Challenges data adequacy based on experimental design concepts. Recognizes when issues may have an impact on areas outside of their immediate area of responsibility. Highlights issues in a timely manner and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise. Experience in reviewing, and executing validation and change control documents, authoring SOPs, Protocols {IQ, OQ, PQ) of Process Control Systems
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.
Quality Assurance (QA) jobs involve ensuring that products, services, or software meet established standards of quality before they reach the consumer. Professionals in QA roles are responsible for identifying defects, implementing test strategies, and ensuring compliance with industry regulations. Key features of QA jobs include attention to detail, a systematic approach to problem-solving, and a focus on continuous improvement. QA specialists work to prevent errors and enhance customer satisfaction by aiming for zero defects and delivering reliable performance.
Quality Assurance (QA) jobs involve ensuring that products or services meet certain standards of quality before they reach the consumer. Individuals in QA roles are responsible for planning and implementing inspection processes, conducting tests, and analyzing the results to detect defects. They work to prevent errors and improve the overall quality of the final output. Key characteristics of QA jobs include attention to detail, a systematic approach to problem-solving, and a strong understanding of industry-specific regulations and quality standards. These professionals play a critical role in customer satisfaction and maintaining the reputation of a brand or company.
