Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies$1. .$1
1001 - 5000
QA Manager - DHR Review
September 11
🏢 In-office - Bay Area
Penumbra, Inc.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies$1. .$1
1001 - 5000
Description
• Oversee team of Quality Specialists in Device History Record (DHR) review • Ensure compliance with regulatory requirements and quality policies • Develop and maintain quality metrics • Evaluate and implement improvements to procedures • Participate in internal and external audits
Requirements
• Bachelor's degree with 4+ years in Quality Assurance or related field, or equivalent combination • Proficiency with Microsoft Office (Word, Excel, PowerPoint) • Knowledge of FDA and ISO 13485 regulations • Demonstrated experience in team management • Strong analytical, problem-solving, decision-making, and leadership skills • High degree of accuracy and attention to detail • Strong oral, written, and interpersonal communication skills
Benefits
• Competitive compensation package • Benefits and equity program, when applicable
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