Summary:Performs functions associated with quality control and quality assurance operations and play a crucial role in ensuring the quality and compliance of our manufacturing processes. This position involves nonconformance event processing and analysis, internal/ external audit support, quality documentation review and processing, and collaborating with cross functional team to main product quality and integrity. May assist in developing methods and procedures for quality assurance and control.Essential Duties and Responsibilities (performance expectations vary by level):Supports quality engineering activities such as change order processing, NCMR investigations, CAPA investigations, execution of validation protocols.Collects data and conducts inspections in the manufacturing process from receiving inspection to product release to support investigations led by Quality Engineers.Support production through more presence on manufacturing line and support inspection team with questions related to methods or processes.May support Quality Engineering with compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).Update and maintain quality assurance protocols and methods for processing materials into partially finished or finished products.Responsible to ensure compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distributionSupport and works on Nonconformance reports including work with cross functional team in nonconformance event assessment, QA verification, material disposition and etc.Performs regular line audit to ensure systems comply with requirements and are effective.To provide assistance and support to the Quality Engineering and Operations function in day-to-day production quality issues and implement correction/ corrective action.Identify opportunities for process/ quality improvement and contribute to continuous improvement initiatives to enhance product quality/ process efficiency.Communicates any concerns about work process regarding environmental impact, health or safety issues to their manager.Able to reads and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools. Able to reviews and interpret engineering drawing and specification.Decision making ability coupled with the ability to work on one's own initiative and with moderate supervision is required.Applies intermediate computer skills in the use of Microsoft Office.Excellent attention to detail.Assumes and performs other duties as assigned.Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily per defined job level. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Experience and Education Requirements: Candidate must possess at least Diploma or equivalent and minimum 2-3 years of related experience. Proven experience in a quality control or related role within manufacturing environment are preferred.Language Skills:Ability to read and interpret procedure, work instruction, schematic and mechanical drawing. Ability to write clear and concise reports, documentation, and emails. Good written communication skills are essential for creating accurate records and conveying finding effectively.Mathematical Skills:Basic mathematic skills are required. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.Reasoning Ability:Ability to think critically and logically to identify the potential causes of quality issue.Physical demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is frequently required to stand, walk, and sit. The employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell. The employee must frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly exposed to moving mechanical parts and fumes or airborne particles. The employee is frequently exposed to wet and/or humid conditions. The employee is occasionally exposed to high, precarious places; toxic or caustic chemicals; and outside weather conditions. The noise level in the work environment is usually moderate.
