What are the responsibilities and job description for the Quality Regulatory position at I3 INFOTEK INC?
Junior Quality Systems & Regulatory Associate
Ann Arbor, MI
2 teams interviews or 1 team/1onsite
Only seeking Jr candidates. Locals preferred, regional okay.
Job Responsibilities:
- Actively work with engineers with equipment assembly and execution of installation and operational qualifications
- Develop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 to meet other relevant standards (MDR and FDA).
- Work closely with product development and manufacturing teams to ensure adherence to quality assurance procedures and requirements and ensure that products meet reliability and quality expectations.
- Hands-on responsibility for quality management system and regulatory compliance, including, but not limited to: document control, design control, risk management, process validation, manufacturing controls, personnel training, quality audits, supplier evaluation, product inspection/testing, nonconforming product control, corrective/preventive actions, product sterilization.
- Manage internal quality audits and external regulatory inspections.
- Analyze product complaints and post market surveillance data and prepare summary reports.
- Work with cross-functional team to streamline design documentation for regulatory submissions.
- Quality and Regulatory documentation consists of design specifications, manufacturing procedures, test methods, specification, and manufacturing drawings and other per quality and regulatory requirements.
- Monitor and interpret regulatory developments and communicate implications to the executive team.
- Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
- Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.
- Ensue QMS system meets FDA and MDR requirements, work with team members to improve quality and characterization test reports.
