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Senior Quality Assurance Engineer

2 months ago

Santa Clara, California, United States Actalent Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Actalent. As a key member of our engineering team, you will be responsible for ensuring the highest quality standards are met in the development and manufacturing of our products.

Key Responsibilities
  • Quality Standards Development: Develop, apply, revise, and maintain quality standards for processing materials and products.
  • Inspection and Testing: Design and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products, components, sub-assemblies, and production equipment.
  • Documentation and Reporting: Prepare documentation for inspection/testing procedures, development studies, validation protocols, and reports. Write technical documents with clarity, detail, and correctness for regulatory review.
  • Guidance and Support: Provide guidance to manufacturing and development engineers on documentation, process controls, data feedback systems, and best quality practices.
  • Project Coordination: Plan, schedule, conduct, and coordinate detailed phases of engineering work in part of a major project.
  • Complex Problem-Solving: Independently perform assignments with an understanding of overall expectations. Receive technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
  • Regulatory Compliance: Ensure personal and company compliance with Federal, State, local, and company regulations, policies, and procedures for Health, Safety, and Environmental compliance.
  • Design Reviews and Risk Management: Participate in design reviews and pre-validation assessments to ensure safe and environmentally sound start-up of new processes. Develop risk management plans for new projects transitioning into manufacturing.
  • Technical Supervision: May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments.
  • Auditing and Compliance: Conduct internal and supplier audits. May be responsible for participating and/or taking a lead role in developing the risk management plan for new projects transitioning into manufacturing.
  • Customer Complaints and Reporting: Process, investigate, and complete customer complaints. Compose technical complaint reports timely and accurately based on reported information and device investigation data.
  • Calibration and Maintenance: Develop and maintain calibration requirements for tools and equipment in the R&D, Manufacturing, and Quality areas.
  • Statistical Analysis: Knowledge of statistics and Minitab, including process capability and data normality assessments, analysis of variance, hypothesis testing, determining appropriate sample sizes, tolerance interval assessments for variable and attribute data, design of experiment (DOE), and variable and attribute sampling plan applications.
Requirements
  • Education and Experience: BS in a related engineering discipline and 3+ years of related experience; or MS in a related engineering discipline and 2+ years of related experience.
  • Industry Experience: Experience in the medical device industry is highly preferred.
  • Technical Writing: Strong technical writing skills are required.
  • Customer Complaint Investigations: Experience in customer complaint investigations and complaint report writing.
  • Manufacturing Support: Experience in manufacturing support as a Quality Engineer.
  • Proactivity and Independence: Must be proactive, self-motivated, and work independently with minimal supervision.
  • Travel: Must be willing to travel up to 10% of the time.
  • Communication Skills: Effective communication skills with all levels of management and organizations.
  • Adaptability: Operate independently and adaptability to changing requirements.
  • Priority Management: Ability to work in a fast-paced environment, managing multiple priorities.