Senior Quality Engineer

About the role

This Senior 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 processes, including automation initiatives, metrics, and dashboard ownership to monitor quality performance.
• Analyze quality issues and project gaps, define technical solutions, and clearly articulate the rationale behind chosen approaches and systems put in place to sustain improvements.
• Support complaint handling and quality investigations, ensuring appropriate documentation, trend analysis, and follow-up actions are completed in a timely and compliant manner.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline.
• 5–10 years of experience in Quality Engineering, Technical Documentation, Manufacturing Quality, or closely related functions within a regulated industry.
• Demonstrated experience supporting Design Control and Design Transfer activities in IVD, medical device, biotechnology, diagnostics, or life sciences environments.
• Proven experience developing and maintaining manufacturing documentation, including SOPs, specifications, work instructions, and other controlled records.
• Experience working within FDA-regulated environments and ISO-compliant manufacturing operations, with a strong focus on quality systems and compliance.
• Strong understanding of Design Control and Design Transfer processes and their application in product development and manufacturing.
• Knowledge of FDA Quality System Regulations (QSR), ISO standards, and Good Manufacturing Practices (GMP).
• Excellent technical writing, proofreading, and document review skills, with the ability to produce clear, accurate, and user-friendly documentation.
• Strong attention to detail and ability to maintain high levels of accuracy in a highly regulated, documentation-intensive environment.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint, and Access, for documentation creation, data analysis, and reporting.
• Experience creating Bills of Materials (BOMs) and managing product structures within ERP/MRP systems, preferably SAP.
• Familiarity with Statistical Process Control (SPC) and quality tools such as Failure Modes and Effects Analysis (FMEA), Pareto analysis, fishbone diagrams, root cause analysis, Six Sigma methodologies.
• Hands-on experience with non-conformance reports (NCR), CAPA processes, complaint handling, and broader quality management system (QMS) activities.
• Strong organizational and project management skills, with the ability to manage multiple projects and deadlines concurrently.
• Excellent communication and collaboration skills, with a customer-service mindset when supporting internal stakeholders.
• Able to work independently while effectively contributing to cross-functional teams and driving documentation-focused initiatives.
• Able to manage multiple priorities and deliver high-quality work in a fast-paced, deadline-driven environment.