The person in this position will establish a plan of continual improvement implementation. Responsible for all International, Federal, State and Local, etc. quality, safety, environmental, regulations and inspections. Occasional travel required.
Must be able familiar with searching engines or any other source to maintain up to date knowledge of applicable regulations for all SLI’s business units
Must be able to understand and interpret regulations
Must create a plan for implementation or regulations and carry on any tasks required to finalize projects.
Must be objective in the review of internal procedures so changes are carried on in an manner that are operationally sound
Ensure design control and product development are in control and compliance.
Evaluate, expedite and improve product development.
Increase quality adherence for all current products.
Conduct, evaluate and direct changes to ensure compliance
Handle all regulatory issues for the filing of 510(k), PMA, etc.
Submits regulatory submissions to the FDA to maintain licenses.
Represent regulatory and quality during FDA inspections.
Adhere to all GMP, ISO, and international regulatory requirements.
Keep abreast of regulatory developments within and/or outside of the company as well as evolving best practices in compliance control. To include plasma collection regulations.
Review and implementation of process improvement and systems to track trends/improvements by department heads.
Establish cost containment goals for the department and plans for implementation, review and tracking.
Implement and maintain the computer system Made-2-Manage as it relates to quality issues.
Evaluate vendors and conduct vendor audits as necessary.
Direct and coordinate investigations and resolution of all complaints related to vendor quality issues.
Direct and coordinate investigations and resolution of all customer complaints related to SLI quality issues.
Meet with customers and vendors as necessary.
Interact closely with customers on new product development.
Other related duties as assigned.
Requires a minimum of 4 years of direct experience in the field.
Familiar with a variety of concepts, practices, and procedures.
Scantibodies Laboratories, Inc., is a 40 year old Biotech company located in the East County of San Diego. The activity of the organization is to develop, manufacture and continually improve products for the diagnosis of disease.