Chief Financial Officer
Applicants send your resume to: mailto:careers@DxUpClose.com
VP of Quality and Regulatory Affairs
- Past experience with startups that have product based business models
- Exceptional negotiation skills and closing financial equity deals
- Skilled at all aspects of financial controls
- Experience with government grant accounting
- Director Medical Device Manufacturing
- Qualify and select external suppliers and contract manufacturers to meet the production needs of the company. Perform internal and supplier quality audits as per 21 CFR 820 and ISO 13485 as needed.
- Write specifications and negotiate contracts with external suppliers
- Plan and manage manufacturing resources including, but are not limited to, external suppliers, labor, equipment, and facilities to meet production schedules and plant goals.
- Develop and maintain quality system & manufacturing procedures, inspection plans, process validations and equipment qualifications (IQ/OQ/PQ).
- Review and execute production schedules. Determines capacity requirements, identifies and solves specific problems relating to the schedule attainment.
- Manage employee relations issues, performance appraisals, increase recommendations, discipline, and hiring and termination recommendations.
- Provide the resources and training necessary to assure adherence to quality system and regulatory requirements.
- Directs the regulation process for products requiring FDA governmental approval by ensuring that all necessary applications are filed and handling all government interactions.
- Familiar with medical devices 510(k) de novo application process, and product payment code application strategies and processes
- Assists in developing procedures to ensure regulatory compliance, including quality oversight, design risk analysis, design history files, document control, complaint tracking.
- Insures that Good Lab Practices are followed and appropriate
- Oversees the quality of the clinical research
Laboratory Supervisor II
- Organizes and directs the daily activities of the laboratory.
- Responsible for supervising laboratory personnel, conducting and overseeing quality assurance and quality control, and collecting, analyzing, and interpreting lab results.
- Ensures that FDA data is organized, stored and archived appropriately.
- Authority for personnel actions and oversees most day to day operations of group, developing standard operating procedures, and scientific experiments. Enforces compliance to CLSI standards.
- Responsible for finding root cause of quality malfunctions, correcting them in a timely way.
- Familiar with hospital antibiotic diagnostics procedures and GLP. Background that includes bacteriology, and bacteriophage.
- Performs a variety of tasks and a wide degree of creativity and latitude is expected.