Quality Engineer - Onsite

Job Description

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.

• Supports one or more instrument platforms on sustaining items such as complaints, nonconformances and day to day issues.
• Sets up and runs audits.
• Participates in teams to ensure documentation compliance.
• Processes CAPAs, change controls, and deviation waivers.
• Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine.
• May take the lead in root cause investigations for issues of moderate complexity.
• Maintain International Organization for Standardization (ISO) and regional regulatory requirements.
• 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.
• Understand and coach others on Quality Systems and procedures.
• Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools.

Cost Center Specific

• 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.