Senior Quality Assurance Manager
1 week ago
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.
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Quality Assurance Senior Manager
2 weeks ago
Indianapolis, IN, United States Harba Solutions Inc. Full timeJobResponsibilities 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...
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Senior Quality Assurance Manager
2 weeks ago
Greenwood, IN, United States US Main Full timeTitle: Senior Quality Assurance Manager Department: Food Safety and Quality Assurance Reports To: VP of Food Safety, Quality & Environmental Safety Position: We seek a transformative Senior Quality Assurance Manager to champion a culture of quality. Interested in this role You can find all the relevant information in the description below. This role drives...
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Senior Quality Assurance Manager
2 weeks ago
Indianapolis, IN, United States Harba Solutions Inc. Full timeJobResponsibilities 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...
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Senior Manager, Quality Assurance
1 day ago
Indianapolis, Indiana, United States DuCharme McMillen & Associates Full timeAs an employee-owned company, DMA prioritizes employees. Low turnover rates and tenured teams are living proof: 2025 Great Places to Work CertifiedEmployee stock ownership program eligibility begins on day one of employment (ESOP contribution is targeted at 6% of your annual compensation)Company paid parental leaveGenerous time off package Multiple...
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Senior Construction Quality Assurance
7 days ago
Indianapolis, Indiana, United States CTI And Associates Inc. Full timeSenior Construction Quality Assurance (CQA) ManagerCTI and Associates, Inc. – Indianapolis, INCTI and Associates, Inc. (CTI) provides geotechnical, environmental, and construction management services to federal, state, municipal, and commercial clients nationwide. For over forty years, CTI has earned a reputation for technical excellence, safety, and...
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Senior Quality Assurance Manager
2 weeks ago
Indianapolis, United States Harba Solutions Inc. Full timeJobResponsibilitiesDevelop, 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...
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Senior Quality Assurance Manager
1 week ago
Indianapolis, United States Harba Solutions Inc. Full timeJobResponsibilitiesDevelop, 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...
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Senior IT Quality Assurance Tester
2 days ago
Indianapolis, IN, United States Elevance Health Full timeAnticipated End Date: 2025-12-30 Position Title: Senior IT Quality Assurance Tester Job Description: Senior IT Quality Assurance Tester Location: This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines...
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Senior IT Quality Assurance Tester
1 day ago
Indianapolis, IN, United States Elevance Health Full timeAnticipated End Date: 2025-12-30 Position Title: Senior IT Quality Assurance Tester Job Description: Senior IT Quality Assurance Tester Location: This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines...
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Senior Quality Assurance Manager
6 days ago
Indianapolis, United States Harba Solutions Inc. Full timeJobResponsibilitiesDevelop, 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...
