3 months ago
GENERAL Assists in the development and coordination of effective quality/reliability programs supporting the pre-production, production, and post-production phases of operations. Performs a variety of technical, special assignments of a complex nature with a minimum of technical guidance. Translates customer's and engineering specifications into actual quality control mechanisms (inspection/test points). Analyzes failures, performs investigations and makes necessary judgments to determine root causes and recommends and implements appropriate corrective action. RESPONSIBILITIES Prepares quality/inspection plans, procedures and instructions in accordance with stated requirements and product specifications. Performs testing and validation of products and production equipment; data analysis and calculations, and make recommendations to changes in equipment, products, or test methods, based on tests/validation results. Reviews manufacturing and assembly planning for appropriate sequenced quality requirements. Prepares appropriate documentation for quality control points throughout the manufacturing/assembly processes. Ensures documentation contains the necessary criteria and provisions to permit effective inspection and testing. Compile and analyze relevant data and determine effective actions to correct and prevent product discrepancies which affect performance and reliability or otherwise do not meet valid customer expectations. Perform investigative research with discrepant materials and quality processes; compile information, analyze issues related to the root causes and initiate corrective action. Monitor and verifies the completion and effectiveness of corrective actions committed to customers or resulting from internal deficiencies. Conducts or participates in internal quality audits, process/product improvement projects, product design reviews, supplier evaluation surveys, discrepant material review and disposition activities, failure analysis, and statistical evaluation/process control activities to resolve and prevent quality/reliability concerns. Perform gage studies and monitor the metrology and calibration activities to ensure quality objectives are being met and that adequate procedures and work instructions are in place and are being followed. Participates in design/process reviews, evaluates the need for possible inspection tooling and/or test equipment. Act as direct quality liaison with Engineering, Manufacturing, Marketing and customers. May serve as Lab Safety Coordinator in conjunction with the company's Hazard Communication Program. AUTHORITY & REPORTING Authorized to control (stop) further processing or shipment of products and services which do not meet customer requirements. Authorized to introduce quality assurance/control mechanisms and preventive activities; apply resolution to quality problems taking corrective actions where needed. Authorized to review and disposition nonconforming material. Reports to the Head of Quality. QUALIFICATIONS Engineering/Life Science bachelor's degree plus 5 yrs Quality Engineering and/or Manufacturing Engineering experience. Practical experience/training in quality planning, Corrective/Preventive action systems, quality auditing, root cause analysis, and problem solving training highly desirable. Ability to communicate orally and in writing; able to express thoughts and concepts, both technical and administrative. Will interface at all organizational levels within the company and with customers and suppliers. Demonstrated ability to proficiently review technical and quality requirements; deal with nonverbal symbolism (i.e., formulas, scientific equations, graphs, etc.) in its most difficult phases. Demonstrate the ability to deal with a variety of abstract and concrete variables for problem solving activities. Good knowledge and skills in the use of advanced personal computer productivity programs for word processing, spreadsheets, database manipulation and flow charts. Demonstrates working knowledge of ISO 9001 quality system and/or FDA 21 CFR 820 quality regulations. ESSENTIAL JOB FUNCTIONS Requires physical mobility and stamina normally associated with sitting, standing, climbing stairs and occasionally extended work hours. Occasionally requires the wearing of protective safety equipment and clean-room attire. Requires periods of prolonged mental and visual concentration for reading, data analysis, and preparation of reports.
Since 1970, Spectrum Laboratories has developed and manufactured innovative products for bioseparation and cell line management. Our products are used for the filtration, isolation, purification and concentration of pharmaceuticals, diagnostics, food, beverages and industrial fluids. We pioneered the development of dialysis membranes and accessories, disposable hollow fiber filtration modules and systems, supported polymeric liquid membranes and preparative low-pressure liquid chromatography products. We have grown to become a global company and we are committed to satisfying our global customers by providing quality products and services. Continuous company improvement is the goal of every employee
We value our employees time and efforts. Our commitment to your success is enhanced by our extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.
10 days ago
only 18 days until close
10 days ago
only 18 days until close