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Collaborates with Operational Leadership, Quality and Operational Excellence to determine corrective action/preventative action needed (CAPA) using critical thinking and independent decision making.
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The Quality Assurance Specialist provides oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supports the Quality Management System.
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Essential Duties and Responsibilities Maintain Supplier Quality metrics that include: Non Conformance Tracking (MRB) Supplier Corrective Action Requests (SCAR) Cost of Poor Quality (COPQ) Train Suppliers to effectively execute Supplier Corrective Action Requests (SCAR) and Corrective Actions Preventive Actions (CAPA.
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Experience in CAPA, support, develop and execute remediation plans. Title: Medical Device Packaging Engineer. Experience in CAPA, support, develop and execute remediation plans. Years’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
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Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering. Bachelor of Science Degree in Packaging Science, Mechanical Engineering, or similar discipline. Responsibilities may include documentation management and/or coordination of Good Manufacturing Practices (GMPs), and may support prototype line development in manufacturing facilities/plants.
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Professional CAPA Investigator. Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories.
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Years of Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering. Education Required: Bachelor of Science Degree in Packaging Science Mechanical Engineering or similar discipline.
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Primary Talent Partners has a 12 month contract opening for a Sr Packaging Engineer with a Medical Device client of ours in Grand Rapids, MI. This role is onsite. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
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Trend CAPA data using Q uality System Reports, charts, and other quality tools as needed. Responsible for managing the Internal CAPA process and administering the customer complaint process in compliance with written procedures and Regulatory requirements , as well as l eading or supporting investigation and process improvement activities.
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Supporting quality improvement projects through Corrective and Preventive Action (CAPA) process. Implements quality improvement projects through Corrective and Preventive Action (CAPA) process.
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