Quality Document Systems Management at Mentis Systems

Duration: 12 + months

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, 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, 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.

This position is based in our Sparks, MD office with a Hybrid work schedule 8:00 AM--5:00 PM EST (Tuesday to Thursday on-site).
This is a temporary position with the possibility of conversion to permanent.
Requires a minimum of a bachelor's degree in science, engineering, or other relevant discipline.
Minimum 3 years 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 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, analyze 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.