Senior Quality Engineer | Sylacauga, AL

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

infrastructure, increased access to energy, resources, and vital services, and made the world a safer, cleaner place.

Differentiated by the quality of our people and our relentless drive to deliver the most successful outcomes, we align our capabilities to our customers’ objectives to create a lasting positive impact.

We serve the Infrastructure; Nuclear, Security & Environmental; Energy; Mining & Metals, and the Manufacturing and Technology markets. Our services span from initial planning and investment, through start-up and operations. Core to Bechtel is our values – ethics, safety, quality, people, culture, relationships, innovation and sustainability, and our covenants – integrity,

respect, collaboration, trust, and delivery. They are what we believe, what customers can expect, and how we deliver. Project Overview: Bechtel Manufacturing & Technology, Inc.

offers engineering, procurement, and construction services for customers in the semiconductor manufacturing, electric vehicle, and data center markets. Headquartered in Reston, Virginia, the M&T global business unit also includes colleagues working in Arizona, Ohio, Texas, India, and additional project locations around the world. Location : Owner facility in Kingston, Georgia, USA Responsibilities: Mechanical QA/QC Consultant Engineer is responsible for establishing, developing, and implementing QA/QC roles while

working with the Mechanical department including, but not limited to the following: Ensuring compliance with codes and regulations Managing all the required quality procedures (ITP, WPS and PQR etc.

) Conducting the inspection Recording all the inspection and test reports by log tracking. Assisting the Contractor by advising in terms of approval of Subcontractor's quality assurance activities Conducting the regular quality audit in conformance with quality assurance program and quality control plan and issuing NCR or CAR Qualifications and Skills: Basic Qualifications: A bachelor’s degree in a university or its equivalent in a Mechanical engineering. A minimum of Ten (10) years of total experience in relevant field for Mechanical QA/QC Consultant Engineer.

Additional Qualifications: Preferred ability in English and shall be good enough for both oral and written. Support the team with all QA/QC activities related Mechanical Works. Support and report to his/her Managers for his/her all roles & responsibilities related to QA/QC works. Coordination work with Construction Department and Design Department to achieve good quality of work. Addendum: Level 1 : B. S. in Mechanical Engineering and a minimum of 10 years related experience. Level 2 : B.

S. in Mechanical Engineering and a minimum of 15 years related experience. #LI-AM3 Shaping tomorrow together Bechtel is one of the most respected global engineering, construction, and project management companies. Together with our customers, we deliver landmark projects that foster long-term progress and economic growth. Since 1898, we’ve completed more than 25,000 extraordinary projects across 160 countries on all seven continents. We operate through five global businesses: Infrastructure; Nuclear, Security & Environmental; Energy; Mining & Metals; and Manufacturing & Technology. Our company and our culture are built on more than a century of leadership and a relentless adherence to our values, the core of which are safety, quality, ethics, and integrity.

These values are what we believe, what we expect, what we deliver, and what we live. Bechtel is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity and expression, age, national origin, disability, citizenship status (except as authorized by law), protected veteran status, genetic information, and any other characteristic protected by federal, state or local law.

Bechtel employees are required to be vaccinated for COVID-19 or show proof of a negative test result prior to accessing Bechtel sites/facilities to the extent required by applicable law or by customer requirements.