Quality Document Systems Management ; Onsite

Position Details

Position: Quality Document Systems Management
Location: Sparks, MD
Duration: 12 Months
Total Hours/week: 40.00
Shift: 1st Shift
Client: Medical Devices Company
Job Category: Quality
Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Work Schedule: Hybrid, 8:00 AM-5:00 PM EST

• Under general supervision, respond to customer and internal requests with information and documents that meet the customer's quality / regulatory needs.
• Provides on-site audit support.
• Maintains existing procedures at the Quality Systems level and below.
• Investigates, analyzes, and develops solutions to a variety of problems of moderate scope and complexity, while using regulations, government guidance documents, and standards, as well as policies and procedures.
• May prepare and maintain product documentation and records for ingredients and OEM products acquired from outside suppliers to support animal by-product and In-Vitro Diagnostics (IVDR) Regulation compliance.
• May contribute to the maintenance of USDA and CDC Import/Transport Permits, and USDA certificates related to product import/export.
• May support maintenance of EDQM TSE Certificates of Suitability.
• May support maintenance of AOAC-RI Certification for identified products.
• May be expected to make presentations at team meetings.
• May support working with government agencies and international associates to assure the required permits, certificates, and related documents concerning animal by-product regulations are in place or provided, and thereby assure the smooth import of acquired materials and export of manufactured products worldwide.
• Requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline.
• Minimum 3 years of experience, or a combination of equivalent education and experience.

• Bachelor’s degree (BS) in a scientific, engineering, or related technical discipline is required.
• 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 externally.
• Ability to work in teams, including large multifunctional teams, and independently obtain results with minimal supervision, using initiative and drive.
• Excellent attention to detail with high accuracy and 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 orally or in writing.
• Must 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.

• Project Management Experience desirable.
• Knowledge of Global Animal By-Product Regulations desirable.
• Knowledge of USP/EP/JP desirable.
• Professional certification is an advantage (e.g., RAC, Six Sigma, etc.).