A global pharmaceutical company is seeking an experienced and detail-driven Senior Manager, Device Quality Assurance to lead quality assurance initiatives for device and combination product development. This pivotal role will provide technical leadership and quality oversight, ensuring regulatory compliance, design control, and robust quality systems. The ideal candidate is a collaborative and motivated quality professional with deep expertise in combination products and a passion for process excellence in a fast-paced, global environment.

Senior Manager, Device Quality Assurance Responsibilities:

• Lead quality assurance activities for combination product development and commercial manufacturing
• Serve as the primary quality lead on design control and risk management
• Oversee quality compliance for design documentation, change management, and supplier performance
• Support sustaining engineering efforts and ensure continuous improvement of marketed products
• Conduct and review complaint investigations, CAPAs, and quality trend analyses
• Represent Accord in internal and external audits and regulatory inspections
• Maintain compliance with 21 CFR Part 4 and relevant ISO/ICH standards
• Drive process development and improvement initiatives to scale quality systems
• Collaborate cross-functionally with Engineering, Regulatory, Operations, and external CMOs
• Offer strategic guidance to senior leadership on device quality and risk mitigation

Senior Manager, Device Quality Assurance Requirements:

• Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
• Minimum 5+ years of QA experience with medical devices or combination products
• Strong knowledge of regulatory standards: 21 CFR 820, ISO 13485, ISO 14971, ICH Q9, etc
• Expertise in statistical quality methods including Gage R&R, capability analysis, MSA
• Experience in medical device manufacturing, supplier management, CAPA, and root cause analysis
• Demonstrated ability to lead projects, communicate across departments, and manage multiple priorities in a fast-paced environment
• ASQ Certified Quality Engineer and/or Six Sigma Black Belt is a plus

Benefits:

• Hybrid schedule
• Comprehensive health benefits
• 401(k) with company match
• Generous PTO
• 10 paid holidays and 2 floating days
• Life/AD&D, STD/LTD Coverage
• FSA Options
• Annual Reviews, Merit Increases, and Promotional Opportunities

Apply now!

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