PlatinumAI is a Chicago-based consulting firm that provides experienced engineering and regulatory consultants to medical device and technology companies, supporting execution across verification, validation, human factors, and compliance-focused programs.
PlatinumAI is seeking Quality and Regulatory professionals to support medical device clients with compliance, documentation, and audit readiness activities.
Overview
Join our innovative team as a Medical Device Quality Engineer and play a pivotal role in ensuring the safety, efficacy, and compliance of cutting-edge medical devices. This dynamic position offers the opportunity to lead quality initiatives, uphold rigorous standards, and contribute to life-changing healthcare solutions. You will be at the forefront of maintaining and improving quality systems, supporting manufacturing processes, and ensuring adherence to global regulatory requirements. Your expertise will help shape the future of medical technology by fostering a culture of excellence and continuous improvement.
Duties
- Develop, implement, and maintain comprehensive quality management systems aligned with ISO 13485, ISO 9001, FDA regulations, and other relevant standards.
- Conduct internal and external quality audits to verify compliance with regulatory requirements and company policies.
- Collaborate with manufacturing teams to establish robust quality control and inspection procedures that ensure product integrity.
- Lead root cause analysis and corrective action initiatives for quality issues identified during production or post-market surveillance.
- Review design documentation, risk assessments, and process validations to ensure adherence to quality standards throughout product lifecycle.
- Facilitate training sessions on quality systems, regulatory updates, and best practices to promote a culture of quality awareness across departments.
- Ability to review and approve test protocols, data analysis, and test reports.
Skills
- Strong knowledge of ISO 13485 standards, FDA regulations, CGMP practices.
- Some knowledge of quality control techniques, quality assurance protocols, and quality inspection methodologies specific to medical devices.
- Analysis skills for problem-solving root causes of non-conformities and implementing effective corrective actions.
- Project management capabilities to lead cross-functional initiatives aimed at process improvement and compliance enhancement.
- Effective communication skills for training teams, preparing documentation, and collaborating with regulatory bodies.
Pay: $70,000.00 - $94,000.00 per year
Work Location: Hybrid remote in Chicago, IL 60617