Harba Solutions Inc.

Compensation

Full Description

JobResponsibilities • Develop, implement, and maintain quality management systems (QMS) in compliance with ISO 13485, FDA, and other applicable regulations. • Lead, mentor, and manage a team of quality assurance professionals. • Oversee internal and external audits, including preparation, execution, and corrective action follow-up. • Review and approve quality documentation, including SOPs, batch records, CAPAs, and deviation reports. • Collaborate with R&D, Manufacturing, Regulatory, and Operations teams to ensure product quality from development to commercial release. • Monitor key quality metrics and drive continuous improvement initiatives. • Ensure timely response to customer complaints, non-conformances, and regulatory inspections. • Lead risk management initiatives and support product change controls. Qualifications • Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred. • 8+ years of experience in quality assurance, with at least 3 years in a leadership role within the medical device, pharmaceutical, or biotech industry. • In-depth knowledge of FDA, ISO 13485, and other applicable quality regulations. • Strong leadership, coaching, and team development skills. • Excellent analytical, problem-solving, and communication skills. • Proven experience with audits, CAPAs, risk management, and compliance documentation.