Quality Assurance Specialist

Description.

Job Duties:

• Perform on-going quality oversight of organization operations including acquisition, contract, and business management support.
• Perform the assessment, development, implementation, and evaluation of program and process components.
• Develop quality processes that meet user requirements. 
• Establish quality goals and engineering approaches which are acquisition phase appropriate, realistic, and feasible in order to meet program cost, schedule, and performance parameters.
• Develop resource-effective quality engineering plans and solutions, as well as innovative approaches to quality process implementation.
• Create and implement quality plans and checklists to support project goals.
• Perform quality planning, quality control activities, and quality assurance audits and reviews. 
• Review and provide comments to candidate quality program plans and documentation, conduct candidate quality audits (as necessary), and assure the delivered product conforms to the candidate’s Technical Data Package (TDP).
• Validate results, report discrepancies, and follow through to ensure that all issues are resolved.
• Provide guidance and instruction to others in performing quality assurance activities (e.g., maintaining quality records, performing quality audits, maintaining quality assurance standards, etc.) in order to meet evolving Industry and Government quality requirements.
• Use approved quality metrics (e.g., process control limits, thresholds, root cause analysis) to evaluate vendor compliance with the requirements and specifications defined in acquisition contracts.
• Coordinate (e.g., preparing and staffing agendas, etc.), participate in, and document (i.e., meeting minutes) project meetings. 
• Prepare briefing materials.
• Provide metrics on each program and conduct internal inspections, including data collection and creation of reports with the appropriate statistical methods.
• Analyze and investigate quality trends or conditions, propose corrective actions when necessary, and monitor results to facilitate continuous process improvement.
• Assist in the development and training of processes that ensure product quality. 
• Perform document control functions (e.g., workflow initiation; tracking; processing; review; distribution; release and maintenance of SOPs, forms, and other quality documents; etc.) in the Livelink electronic document management system.

Required Knowledge, Skills and Abilities

• Possess knowledge of quality assurance principles and practices as a function of a Quality Management System (QMS).
• Possess knowledge of the relationship of QA to other activities (e.g., program management, contract administration, technical requirements, etc.).
• Possess knowledge in Industry-accepted quality standards (i.e., International Standards Organization (ISO) 9001 philosophy, regulations, and Industry technical data convention).
• Possess expertise in reviewing requirements, specifications, and documentation to gain a thorough understanding of the programs and processes to be certified.
• Capable of establishing effective interpersonal relationships, as well as communicating efficiently, both in writing and orally.
• Possess a comprehensive knowledge of the Microsoft Office suite of software (e.g., Word, Excel, PowerPoint, etc.) to create documents, reports, and presentations.
• The candidate shall possess knowledge of the relationship between QA and FDA regulations.
• Possess experience in conducting studies and investigations and root cause/problem analyses and developing logical documented recommendations.
• Possess, at minimum, a Lean Six Sigma green belt certification, or its equivalent.

Clearance Level:

Location:

Chimera Enterprises International is an Equal Opportunity/Affirmative Action Employer committed to hiring and retaining a diverse workforce, including protected veterans and individuals with disabilities.