QA Engineer
QUALITY ENGINEER Job Purpose:The Quality Engineer provides quality engineering and assurance to ensure products and services are produced to exceed customer requirements and expectations. The Quality Engineer works in conjunction with other business and engineering disciplines using a cross-functional approach to ensure new/improved and current products and processes are in compliance with applicable Quality Management Systems, standards and regulations. Assist the department in the maintenance of ISO 13485. Conduct internal and supplier audits as required. Analyzes reports and returned products and recommends corrective action.
Nature of Duties: - Lead quality planning activities for new product release projects, including verification and validation plans
- Contributes to validation planning for new and existing processes
- Initiate or assist in cost reductions of product inspections
- Ensure effective product engineering control and transfer to production
- Provide validation, sampling, and statistical analysis support to other functions in the organization
- Works under indirect supervision following established practices and clear-cut policies in the performance of majority of duties
- Provide assistance with maintenance of an ISO 13485 compliant system.
- Provide day-to-day quality engineering support for specific customer programs
- Interface closely with operations, manufacturing and test engineering, along with program
management, in all aspects of the customer program - Responsibility, Authority and Accountability for customer Product and Process Quality including continual quality improvement, risk analysis and reduction, as well as corrective and preventive action responses
- Customer interface for all regular Quality Engineering level communication
- Utilize Six Sigma methodologies for process improvement.
Education and Experience : - Bachelor's Degree in Electrical, Electronic, Industrial Engineering or similar
- 5+ years Quality Engineering experience in a manufacturing environment, preferably in the medical device industry.
- Experience with and solid knowledge of ISO 13485 and one or more of the following quality management systems ( ISO 9001, TL9000)
- Solid experience with medical core tools i.e PFMEA, Control Plans, SPC, MSA. Experience with validation processes (components, process and design)
- Lean/ Six Sigma implementation experience preferred
- Able to define and/or interpret problems, collect data, establish facts and draw valid conclusions
- Effectively communicate with co-workers, customers, and suppliers
- Interpret an extensive variety of industry standards, technical instructions, drawings, and specifications
- Have a thorough understanding of problem-solving and quality improvement tools and techniques. This includes knowledge of management and planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements
- ASQ Certification as a Quality Engineer or Six Sigma Green/Black Belt desired.
Skills and Ability Expectations - Problem solving using root cause methodologies
- Applying statistics and software in data analysis
- Application of failure modes and effects analysis (FMEA)
- Excellent organizational and communication skills
- Flexibility for handling a wide range of activities
- Ability to work under pressure, multi-task, and prioritize tasks with strict deadlines
- Teaches others new processes and procedures.
