Quality Engineer II

• Basic knowledge of quality systems regulations, ISO Quality System and Medical Device standards.
• Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
• Ability to work in teams, including large multifunctional teams, and independently obtain results as required with minimal supervision.
• Proven ability to use initiative and drive to achieve results.
• Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations.
• Ability to identify, analyze, develop, and present solutions for problems of moderate scope and complexity.
• Ability to collect, analyze data and present results to others orally or in writing.
• Must be able to comprehend and summarize data and document into reports.
• Must be Self-motivated, organized and detail oriented.
• Ability to handle multiple task assignments and effectively manage time and priorities to meet deadlines.
• Ability to develop work plans and manage them to meet agreed upon goals.
• Skilled in Microsoft software; excellent Excel data extraction and analysis skills; SAP proficiency strongly preferred; ability to learn and master other software programs

• Quality Engineer II is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems.
• Quality Engineer II uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools.
• Works with variable enterprise systems/Corporate directives to support new and/or current product lines and processes.
• Typical assignments may include supporting one or more instrument platforms on sustaining items such as complaints, nonconformances and day to day issues, supporting audits, actively participating in teams, ensuring documentation compliance, processing of CAPAs, change controls, and deviation waivers.
• Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine. Quality Engineer II may take the lead in root cause investigations for issues of moderate complexity.
• Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.
• Develop Device History Files and maintain in a manner consistent with regulatory requirements.
• Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers.
• Supports the coordinated integration of new products into Manufacturing / Operations.
• Ensures DS Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
• Understanding and coaching others on Quality Systems and procedures.
• Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools.

• Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision.
• Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations.
• Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills.
• Knowledge of manufacturing processes, use of statistical tools required, and knowledge of biological/chemical test methods are preferred.
• Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred.

Pavan.p@sunrisesys.com