Documentation Specialist

Position Summary: * The Quality Assurance Engineer provides technical support for various quality system processes to help ensure excellent product quality throughout product lifecycles. Position Responsibilities: * Drive continuous improvement actions focused on product quality. * Works with Engineering and Manufacturing to develop acceptance criteria for production processes. * Analyzes production quality data to identify trends or issues which require action or CAPA activity. * Assists in creating and implementing procedures in the quality management system. * Assists in the review and disposition of nonconforming materials. * Assists in the creation and validation of manufacturing processes. * Reviews manufacturing process and part deviations. * Creates quality alerts when acceptance activities need to be adjusted. * Supports external regulator or customer audits * Provides response to inquiries related to quality assurance arising from tenders or other sales efforts. * Performs other duties as requested. Essential competencies: * Bachelor of Science degree in Engineering or related field. * Experience with manufacturing / quality methodologies such as cc etc. * Understanding of statistical analysis techniques and tools. * Experience with formal quality systems such as ISO 13485 or ISO 9001. * Proficiency in reading and understanding technical product documentation (diagrams, schematics, flow-charts, etc.) * Proficient in the use of Microsoft Office tools such as Word, Excel, PowerPoint, Outlook, etc. * Comfortable with using PC tools and Windows OS, with a working knowledge of local and network based file systems. * Excellent verbal and written communication skills using the English language. * Able to coordinate multiple activities and actions of persons contributing to assigned tasks. * Detail oriented with good organizational and record keeping skills. * Ability to work independently and as part of a team. * Proactive and timely in execution of assigned tasks. * Able to be flexible and adaptable when needs and priorities change. Physical demands and work environment: * Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. * Work environment: The work environment is in an office setting with minimal noise level.