Senior Quality Engineer

Job Title:

Quality Engineer

Job Description

This Quality Engineer (Quality Engineer III - Design Transfer & Technical Documentation) role supports design transfer and technical documentation within a regulated manufacturing environment. The position partners closely with R&D, Manufacturing, Quality, Engineering, and Scientific teams to develop, review, and implement high-quality documentation required for product transfers, process changes, and ongoing manufacturing operations. The role focuses on translating Design Control outputs into manufacturing-ready documentation, ensuring accuracy, compliance, and continuity as products move from development into full-scale production.

Responsibilities

* Develop, edit, review, and finalize technical documentation that supports design transfer activities from development into manufacturing.

* Partner with R&D and scientific teams to translate technical transfer memorandums and Design Control documentation into clear, manufacturing-ready work instructions and procedures.

* Create and maintain Standard Operating Procedures (SOPs), manufacturing instructions, specification sheets, worksheets, and other controlled documents to support production.

* Design and implement documentation formats and layouts that improve usability, consistency, and regulatory compliance.

* Process and implement document changes, procedure revisions, and engineering change activities in accordance with established quality system requirements.

* Ensure all documentation accurately reflects approved processes, products, and manufacturing requirements, maintaining high standards of precision and clarity.

* Support quality system compliance activities in accordance with FDA Quality System Regulations (QSR), ISO standards, Good Manufacturing Practices (GMP), and internal procedures.

* Drive documentation quality and consistency across manufacturing and technical operations to support reliable and compliant production.

* Support investigations, corrective actions, and preventive actions (CAPA) by documenting root cause analyses and implementing approved quality changes.

* Prepare and review non-conformance reports (NCR) and complaints, focusing on backlog reduction and timely resolution in alignment with quality system processes.

* Identify opportunities to improve documentation workflows, quality processes, and overall operational efficiency, and recommend practical solutions.

* Maintain document traceability and ensure proper document control practices, including version control and approval workflows, are consistently followed.

* Lead or participate in cross-functional documentation and process improvement projects aimed at enhancing design transfer and manufacturing readiness.

* Collaborate effectively with Manufacturing, Quality, R&D, Engineering, and Scientific personnel to support product transfers, process implementation, and scale-up initiatives.

* Build strong working relationships across departments to ensure alignment on documentation requirements and successful execution of technical projects.

* Provide guidance and subject matter expertise on documentation requirements, quality standards, and best practices to project teams and stakeholders.

* Create and maintain part numbers, Bills of Materials (BOMs), and related records within ERP/MRP systems, such as SAP, to ensure accurate product structures.

* Support the implementation and maintenance of manufacturing documentation within quality management systems (QMS) and enterprise systems, including document control platforms.

* Ensure accurate and timely updates to controlled documentation and manufacturing records, maintaining data integrity and compliance with regulatory expectations.

* Identify and support process improvement opportunities using Lean and quality improvement methodologies to enhance quality, compliance, and efficiency.

* Utilize problem-solving tools and quality techniques, such as FMEA, Pareto analysis, fishbone diagrams, root cause analysis, Six Sigma methodologies, and 5 Whys, to improve documentation processes and manufacturing readiness.

* Contribute strategically to the development and standardization of quality…