Engr , Quality

Job Description

Bill is $63.80 Quality Engineer II is responsible for the application and interpretation of plant/department procedures to ensure consistency/compliance with Quality Systems, employment of appropriate statistical and analytical tools, and support for product lines and processes.

Key responsibilities include:

• Supporting instrument platforms on sustaining items such as complaints, nonconformances, day-to-day issues, audits, documentation compliance, CAPAs, change controls, and deviation waivers.
• Frequent interaction with functional areas such as Research and Development, Operations, etc., and leading root-cause investigations for moderate-complexity issues.
• Maintaining ISO and regional regulatory requirements with focus on quality across product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.
• Developing and maintaining Device History Files in compliance with regulatory requirements.
• Generating process/product quality information in the form of CTQ indices, recommendations, and solutions to emerging issues for sharing with project teams, operations, and suppliers.
• Supporting coordinated integration of new products into Manufacturing and Operations.
• Ensuring DS Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are compliant with all applicable regulatory policies.
• Coaching others on Quality Systems and procedures.
• Performing trend analysis, risk management (FMEA, Hazard Analysis, Fault Tree) and applying Six Sigma tools.

• Skilled in working in a team environment, performing multiple tasks, managing conflict, and driving results with minimal supervision.
• Knowledge of GLP/GMP/ISO requirements and strong understanding of the pertinent Quality System/Regulations.
• Computer skills in word processing, spreadsheets, and statistical packages required; excellent communication skills.
• Knowledge of manufacturing processes, use of statistical tools, and familiarity with biological/chemical test methods preferred.
• Experience using statistical methods required.
• Familiarity with Design Control requirements and knowledge of Medical Device Validations preferred.