What are the responsibilities and job description for the ARPA-H Senior Quality Management Systems Engineer Technical SETA position at Lexical Intelligence, LLC?
Job Description
Job Description
Salary : $110,000 - $140,000
Requisition Description :
Are you a passionate Quality Management Systems Engineer with expertise in supply chain management and a deep understanding of global supply chain operations? Are you ready to support the Advanced Research Projects Agency for Health (ARPA-H) in their mission to accelerate better health outcomes for everyone by supporting complex and leading-edge research and development (R&D) projects designed to arrive at high-impact solutions to society's most challenging health problems?
Lexical is seeking a Senior Quality Management Systems Engineer to serve as a Scientific Engineering Technical Advisor (SETA) in support of an ARPA-H Program Manager (in the Eastern Time Zone) and work in our Remote office. This role will support a new ARPA-H program that seeks to enhance performance of the US Supply Chain through quality solutions, market and regulatory analyses, technical due diligence, and bringing to light industry standard practices that align.
In this role, you will collaborate with the ARPA-H Program Manager and team to effectuate bold ARPA-H research initiatives, support the development, funding, and management of new and existing R&D programs to meet ARPA-Hs mission to accelerate better health outcomes for everyone. More detailed requirements below.
These SETA duties include but are not limited to :
- Contribute to a multidisciplinary team that will develop, scale, and drive adoption of quality solutions to enhance performance of the US Supply Chain.
- Provide subject matter expertise in pharmaceutical and medical device facility inspections, product review boards and audits of global quality and regulatory assurances. Successful implementation of an electronic Quality Management System (QMS) in a large matrixed organization or proficiency with ISO 9001 requirements, as well as minimum requirements for storage, handling, and distribution of materials and prescription drug products.
- Evaluate technical proposals for scientific merit and innovation. Provide feedback, organize reviewer comments, draft recommendations and project summaries, and presentation materials.
- Perform market and regulatory analyses, technical due diligence, literature reviews and generate briefing documents summarizing technical topics related to digital transformation initiatives within the supply chain; leveraging AI, machine learning, and IoT technologies to drive operational efficiency and manage risks throughout global supply chain networks.
- Develop technical and administrative programmatic documentation on short timelines to communicate technical approach, progress, cost, schedule and risk for advanced technology development efforts.
- Assist, support and provide advice to the Program Manager to further the development and progress of new and existing programs.
Qualifications :
Additional Experience :
Salary and benefits
We offer a competitive salary and a generous benefits package, including full health and dental, HSA and retirement accounts, short- and long-term disability insurance, life insurance, paid time off and 11 federal holidays.
Equal Employment Opportunity Policy
Lexical Intelligence, LLC, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Salary : $110,000 - $140,000
