Quality Assurance Specialist
hace 1 mes
We are seeking an experienced Quality Assurance Specialist to join our team in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.
Responsibilities: Ensure compliance with FDA, ISO 13485, and other applicable regulations and standards throughout the product lifecycle.Conduct quality reviews and audits of processes, systems, and documentation to ensure adherence to quality standards and procedures.Support the development and implementation of quality assurance procedures and work instructions for manufacturing, testing, and inspection.Review and approve design history files, validation protocols, test plans, and reports to ensure product quality and compliance.Investigate and resolve non-conformances, CAPAs, and deviations, ensuring timely implementation of corrective and preventive actions.Participate in risk management activities, including the development and review of risk assessments, FMEAs, and control plans.Collaborate with cross-functional teams to identify and implement continuous improvement initiatives that enhance product quality and process efficiency.Prepare and present quality metrics, trends, and reports to management and stakeholders to support data-driven decision-making.Provide quality oversight during product transfers, process changes, and new product introductions.Support internal and external audits, representing the Quality Assurance team in audits conducted by regulatory agencies and notified bodies. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field.3+ years of experience in quality assurance in the medical device industry.Strong knowledge of FDA, ISO 13485, and other regulatory standards.Experience with CAPA management, risk assessments, and validation activities.Excellent analytical and problem-solving skills.Strong communication and teamwork abilities.
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Quality Assurance Specialist
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Caimito Barrio, Puerto Rico Abbott A tiempo completoAbout AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.Job DescriptionWe are seeking a highly skilled Quality...
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Senior Quality Assurance Specialist
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Credentialing Quality Assurance Specialist
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Quality Assurance Trainee
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Software Quality Assurance Manager
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Head of Quality Assurance
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Compliance Quality Assurance Manager
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Senior Quality Assurance Specialist
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Caimito Barrio, Puerto Rico Penumbra A tiempo completoJob SummaryWe are seeking a highly skilled Senior Quality Engineer to join our team at Penumbra, Inc. in Alameda, CA. As a key member of our quality team, you will be responsible for ensuring the highest quality standards in our commercial manufacturing of interventional medical devices.Key ResponsibilitiesProvide technical guidance and support to operations...
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Senior Quality Assurance Specialist
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Caimito Barrio, Puerto Rico Penumbra A tiempo completoJob SummaryWe are seeking a highly skilled Senior Quality Engineer to join our team at Penumbra, Inc. in Alameda, CA. As a Senior Quality Engineer, you will play a critical role in supporting commercial manufacturing of interventional medical devices. Your primary responsibilities will include planning and conducting work requiring judgment and independent...
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Senior Operations Quality Assurance Manager
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Compliance Quality Assurance Manager
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Caimito, Puerto Rico Actalent A tiempo completoJob Title: Quality Assurance ManagerJob DescriptionAnalyze user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization. Gather and document user and functional requirements. Participate in the authoring and execution...
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Quality Assurance Specialist
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Compliance Quality Assurance Systems Manager
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Sr. Manager
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Director of Quality Assurance Data Analytics
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Caimito Barrio, Puerto Rico Jobleads-Us A tiempo completoJob SummaryAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...
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Product Quality Assurance Specialist
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Caimito Barrio, Puerto Rico Abbott A tiempo completoProduct Quality EngineerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than...
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Director/Sr. Director, Quality Operations
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Quality Compliance Specialist
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