Position : Quality Engineer - Onsite

Location : Sparks, MD

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client : Medical Devices Company

Job Category : Engineering

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT

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.
• 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.

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.