What are the responsibilities and job description for the Spec 2, Quality Document Systems Management - Immediate Requirement position at MillenniumSoft Inc?
Position : Spec 2, Quality Document Systems Management
Location : Sparks, MD
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Professional
Level of Experience : Mid-Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Job Description
Location : Sparks, MD
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Professional
Level of Experience : Mid-Level
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Job Description
- Under general supervision, responds 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, analyses, 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, for guidance.
- 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, export of manufactured products around the world.
- 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 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, analyse 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.
- 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.).