Senior Quality Assurance ManagerHarba Solutions Inc. • Indianapolis, IN, United States
Senior Quality Assurance Manager
Harba Solutions Inc. • Indianapolis, IN, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]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.
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
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