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Quality Assurance Engineer II

2 months ago

Corona, California, United States Agiliti Full time

Position Overview: The Quality Control Engineer II will implement and uphold quality assurance systems and methodologies in partnership with Agiliti's manufacturing and design teams, ensuring compliance with internal standards, customer expectations, and regulatory mandates.

Key Responsibilities:

  • Conduct quality assurance activities for both new and existing products, as well as process enhancement projects.
  • Utilize systematic problem-solving techniques and Statistical Process Control (SPC) methods to identify, prioritize, communicate, and resolve quality challenges.
  • Create and sustain product control plans and inspection protocols for raw materials, in-process materials, and final products.
  • Work collaboratively with Design, Manufacturing, and Supply Chain departments to evaluate supplier performance.
  • Analyze supplier performance metrics, identify trends, and proactively address any discrepancies or concerns with suppliers.
  • Assist in the planning, execution, and upkeep of equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Engage in and potentially lead Material Review Boards (MRB) to support investigations and decisions regarding product nonconformities.
  • Oversee review processes to maintain medical device documentation resulting from engineering change orders, including Risk Management, Process Failure Mode and Effects Analysis (FMEA), and Quality Control Plans.
  • Participate in the execution of verification and validation testing protocols.
  • Contribute to projects and cross-functional teams, potentially leading mid-scale initiatives.
  • Lead Corrective and Preventive Action (CAPA) investigations and the implementation of action items.

Qualifications:

  • Bachelor's Degree in Engineering, Science, or a related technical field is required.
  • 3-5 years of relevant experience, ideally within a medical device manufacturing context.
  • Familiarity with New Product Development processes.
  • Experience with FDA 21 CFR Part 820 Quality System Regulation is essential.
  • Knowledge of ISO 13485:2016 for Medical Devices is required.
  • Experience with ISO 14971 Risk Management is preferred but not mandatory.
  • Experience with metrology equipment and laboratory practices is advantageous but not required.
  • Background in electronics or PCB manufacturing is desirable.
  • Experience in working with and qualifying automation equipment is beneficial.
  • Proficient in statistical analysis software for SPC and CPk Analysis.
  • Experience with tooling and fixture qualification, including First Article Inspection (FAI) and Gage R&R.

Skills and Competencies:

  • Bilingual in Spanish is an asset.
  • Proficient in MS Office Suite, including MS Project and Visio.
  • Working knowledge of CAD software is preferred (e.g., SolidWorks, Autodesk).
  • Strong analytical capabilities and meticulous attention to detail.
  • Excellent technical writing and communication skills.
  • Strong presentation, facilitation, and project management abilities.

This job description is intended to provide a general overview of the position and does not encompass all tasks that may be required. The incumbent is expected to perform other duties as necessary for the effective operation of the department.