Senior Quality Engineer

Job Title: Senior Quality EngineerJob Description 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. Work independently while effectively contributing to cross‑functional teams, managing multiple priorities in a fast‑paced, deadline‑driven environment. Essential Skills 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, and 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. Ability to work independently while effectively contributing to cross‑functional teams and driving documentation‑focused initiatives. Ability to manage multiple priorities and deliver high‑quality work in a fast‑paced, deadline‑driven environment. Additional Skills & Qualifications Master's degree in Engineering, Life Sciences, or a related scientific discipline is preferred. Experience in In Vitro Diagnostics (IVD) manufacturing and familiarity with diagnostics product lifecycles. Experience supporting product launches, design transfers, and manufacturing scale‑up initiatives in regulated manufacturing settings. Experience with technical change management processes and electronic document control systems. Exposure to TrackWise or similar quality management and complaint handling systems is a plus. Experience with Lean Manufacturing or Six Sigma methodologies, including formal training or certification, is highly desirable. Background in managing NCR, CAPA, and complaint backlogs, with a focus on prioritization and timely resolution. Experience applying structured problem‑solving approaches such as 5 Whys and fishbone diagrams to drive sustainable quality improvements. Ability to think strategically from a quality perspective, contributing to the standardization and automation of quality processes and systems. Comfort with owning quality metrics and dashboards, and using data‑driven insights to guide process improvements. Demonstrated ability to lead projects, clearly define problems and gaps, and explain how technical solutions were designed and implemented. Ability to design and implement systems and controls that sustain improvements after problems are solved, ensuring long‑term process stability. Work Environment This full‑time position is based in Fremont, CA within a technical operations and manufacturing setting that supports regulated IVD, medical device, biotechnology, diagnostics, or life sciences products. The role involves working in both office and manufacturing environments, with frequent use of computers and enterprise systems for extended periods. You will collaborate closely with cross‑functional teams in R&D, Manufacturing, Quality, Engineering, and Scientific functions, often in a fast‑paced, deadline‑driven atmosphere. The work environment emphasizes strong quality culture, continuous improvement, and adherence to FDA, ISO, and GMP requirements. You should be comfortable managing multiple projects simultaneously, moving between documentation‑focused tasks at a workstation and interactions on the manufacturing floor as needed. The setting supports the use of ERP/MRP systems such as SAP, quality management systems, document control platforms, and standard office productivity tools to perform daily responsibilities. Job Type & Location This is a Contract position based out of Santa Clara, CA. Pay and Benefits The pay range for this position is $56.50 - $56.50/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Santa Clara,CA. Application Deadline This position is anticipated to close on Jul 16, 2026. Legal Notices The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr