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Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable. Responsibilities : Perform quality activities related to the IVD development activities which includes providing guidance for design controls, risk management, change control, and decisions on product development activities to ensure continued compliance with internal procedures and applicable regulations.
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Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness. Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills Experience with pharmaceutical and/or device quality and compliance management systems, desired.
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Responsibilities: Providing root cause analysis of design, process and quality issues found on the production floor during prototype builds. Experience with SolidWorks CAD design preferred ability to interpret engineering drawings required.
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Work cross-functionally with Manufacturing, Project Management, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, Information Technology (IT), and Maintenance.
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Experience with electronic requirement data management SW – preferably DOORS Minimum five years engineering / R&D experience in a rigorous quality-focused environment Minimum three years' experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines Excellent requirements and specification writing skills.
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Supporting cGMP quality improvement efforts at iCTC (Philadelphia, PA) and in remote facilities such as IOVA (Philadelphia, PA) and the Tampa Labs (Tampa Bay, FL). Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes and disposition of discrepant material.
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Responsibilities: Manager is looking for the below: Manager is looking for a Supplier Quality Engineer who is comfortable speaking and working both on the line to determine if issue is material and speaking to the supplier/vendor regarding the issue to get it resolved.
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Ensure that manufacturing has accurate and detailed information on specifications, with customer manufacturer under corresponding QMS (Quality Management System). Partner with R&D, Quality, Regulatory Affairs and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
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Employee will be required to work closely with both manufacturing, quality, and engineer associates. Biopharma Process Experience Minimum of 10-15 years' experience in validation (with degree 10+: without 15+), biological quality assurance and/or quality control in an FDregulated biotechnology or pharmaceutical company with progressive levels of responsibility.
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4-5 years Mandatory experience in Automotive domain or Aerospace domain as Supplier Quality Engineer. Mandatory experience in evaluating PPAP documentation and align with Parker Quality requirements.
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Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE) preferred. Coordinate and support supplier quality management activities, including qualification and evaluation, supplier investigations, etc.
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May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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Knowledge on Lean manufacturing, Value stream Mapping, Total quality management, Kaizen, s, Material tracking – Kanban, Poke - Yoka etc. Experience in ensuring the update, quality and consistency of key parameters of supply and stock management (eg.
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Execute commissioning and qualification activities for utilities systems, ensuring adherence to project schedules and quality standards. Coordinate with cross-functional teams including engineering, quality assurance, operations, and validation to ensure successful project outcomes.
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Requirements: + years' experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a regulated industry Experience with ISO , CR , ISO , EU MDR, IEC -, IEC , and IEC standards.
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quality engineer jobs Company: Katalyst Healthcares Life Sciences
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