Quality Manager | Arab, AL

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.

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.

Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.

bills of material, specifications, etc. ) in order to: Identify and resolve issues affecting product configuration Identify and assign rework actions necessary to rework production product Accept production product work-in-process and approve for next assigned operation Skills : Candidates must be able to work in a self directed manner in a fast-paced working environment Foster and maintain professional and productive relationships with other staff and management Possess excellent verbal and written communication skills Demonstrate proficiency in computer based applications Have experience with electronic assembly including; SMT, T/H & Mechanical Ability to effectively operate visual magnification

devices (scope) Ability to effectively operate and interpret basic electronic measuring devices Ability to effectively operate and interpret basic mechanical measuring devices Qualifications : High school diploma or equivalent required, some college preferred Basic math skills required Acceptable visual acuity and eye-hand coordination Must have, or be able to acquire, operator certification for IPC-A-610 Must have, or be able to acquire, operator certification for J-STD-001 Ability to review and interpret technical data packages for electronic assemblies Physical Demands : While performing these duties, the employee is required to sit or stand for extended periods of time, reach with hand and

arm, and talk or hear.

Employee may be required to lift up to 50 pounds.

This position may require exposure to information which is subject to US export control regulations, i. e. the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR). All applicants must be U. S. persons within the meaning of U. S. regulations. Job Posted by Applicant Pro