
Khaled Sheira
Quality Assurance Manager at Azenta Life Science
New York City, United StatesWork Experience
Senior ManagerFull Time
Azenta life Science
Jan 2023 - Present -2 yrs, 6 months
United States , Newark
- Job Details:Overseeing end-to-end project execution, implementing best practices, and providing strategic direction, including but not limited to regulatory compliance, risk management, and • Lead and manage the Project Management Office (PMO), ensuring effective planning, execution, and closure of projects. • Collaborate with cross-functional teams to define project scope, goals, and deliverables. • Develop and implement project management methodologies and best practices. • Oversee project budgets, timelines, and resource allocation. • Provide strategic guidance to project managers and teams. • Conduct and ensure monthly project reviews and report on project progress to executive leadership. • Identify and mitigate project risks and issues. • Foster a culture of continuous improvement within the PMO. • Complies established ISO 9001, ISO 13485, ISO 21500 and Quality procedures and standards of operation. • Improve current PDI project techniques and ensure compliance with ISO 13485 project management requirments.
Quality Assurance ManagerFull Time
Azenta Life Science
Jan 2022 - Present -3 yrs, 6 months
United States
- Job Details:Drive improvement through oversight and management of the divisional quality system for the Genomics operations, including but not limited to regulatory compliance, risk management, and • Plan, direct, and coordinate the efforts of Quality Assurance (QA) team members and QA activities towards maintaining an effective quality management system (QMS) • Engaged with senior management and leadership to set measurable business and team quality objectives, tracks performance against them and organizes management review of the QMS • Managed, Maintained and Improved the QMS to achieve company quality objectives and meet the quality and regulatory standards needed by the business units. • Complies and enforces established College of American Pathologists (CAP), Good Laboratory Practices, Good Manufacturing Practices, Good Clinical Practices GLP 21CFR58, CLIA and Quality procedures and standards of operation. • Lead the implementation of quality system in global branches of Azenta. • Facilitated alignment of QMS and quality activities across departments to ensure adherence to Azenta quality standards and goal of meeting and exceeding customer requirements • As a certified Lead Auditor Trained and Lead regular internal facility and study audits to ensure compliance to our quality system and governing regulatory body requirements and coordinates external audits from clients or a third-party • Initiated continuous improvement activities and CAPA program based on data from quality measuring and monitoring activities such as audit findings, customer feedback, deviations, non-conformance, etc.
Quality EngineerFull Time
Power Container Corp
Aug 2020 - Aug 2021 -1 yr
- Job Details:Responsible for the implementation and continuous improvement of all necessary equipment and processes required for the successful execution of the Quality Group. Also analyzing daily internal and external quality issues and communicating them to the rest of the plant. • Manage quality related issues, including internal non-conformances, supplier corrective action requests, customer complaints and audit findings. • Activities include root cause investigation, record capturing, development of corrective and preventive action and escalation of quality issues as appropriate. • Maintain and update lab equipment as needed including management of the calibration program. • Help ensure compliance to ISO systems with support of corporate and division specific goals. Page 2 • Provide direction to ensure continuous improvement of such processes and systems. • Review and update procedures in order to maintain compliance to ISO with the goal of continuous improvement.
Project Manager/ Lead AuditorFull Time
USQC
Aug 2019 - Dec 2021 -2 yrs, 4 months
United States
- Job Details:Project Lead of US east coast region, managing various key personnel and projects to fulfil and achieve the required level of customer satisfaction and ISO regulated work environment. • Lead and manage quality-focused projects including effective project management, coordination, and deployment of resources, and writing and delivering reports • Manage and Conduct audits/assessments of processes and quality systems (ISO, external & internal audit, etc) • Conduct training for different ISO and Internal auditor certification
Education
Bachelor's Degree in Industrial and Product Design Engineering
Ain Shams University (ASU)Jan 2015
High School - Thanaweya Amma
Mubarak experimental language schoolJan 2004
Skills
- Operations Management
- Operations Planning
- • Statistical process control (SPC)
- Capability studies (CPK)
- • Quality System, CAPA and NCMR management
- Lean Six Sigma
- CAD Drafting
- Autodesk Inventor
- AutoCAD
- SolidWorks
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Languages
Arabic
FluentEnglish
Fluent
Training & Certifications
Six Sigma Black Belt
NJIT·2018Certified Project management
2018Lead Auditor
ASC·2018TOEFL
Amedeast·2006