**Principal Quality Assurance Engineer**

4 days ago


Santa Clara, California, United States Cirtec Medical Full time
About the Role

We are seeking a highly skilled and experienced Principal Quality Assurance Engineer to join our team at Cirtec Medical Corporation. As a key member of our quality assurance team, you will be responsible for developing, implementing, and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.

Key Responsibilities
  • Lead quality engineering support to new product development, operations, and quality systems
  • Develop and maintain quality engineering methodologies, systems, and practices
  • Provide direction in implementing incoming inspection, first article inspection, in-process, and final product inspection plans
  • Develop and justify sampling plans with characterization of test/inspection methods
  • Author, review, and approve documentation for design control activities
  • Assist in qualification activities associated with supplier/vendor design characterization requirements
  • Provide leadership engineering technical expertise and guidance for site-level quality functions
  • Support and enforce quality best practices and GDP/GMP continuous improvement efforts
  • Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
  • Ensure quality requirements are communicated and met at suppliers
  • Review manufacturing records to perform lot release activity
  • Provide quality project management support as needed
  • Develop and maintain standard operating procedures
  • Develop and maintain project quality plans
  • Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development
  • Lead the development and implementation of IQ and OQ protocols
  • Ensure compliance of all site personnel to corporate and site-level QMS and training requirements
  • Administer employment practices, including monitoring time and attendance, hiring, terminating, counseling, and disciplinary actions
  • Own or approve supplier quality activities, including supplier approval and maintaining and assessing supplier performance data
  • Provide audit support for third-party audits, customer audits, and internal audits
  • Support the implementation of continuous improvement initiatives
  • Develop and maintain control plans
  • Initiate and maintain SPC for production processes
  • Lead FMEA and DOE as applicable
Requirements
  • Bachelor of Science in biomedical, mechanical, or materials engineering discipline
  • 10 years minimum experience in medical device environment, catheter experience preferred
  • Fluency in use of computer systems for data analysis, specifically Microsoft Office
  • Excellent verbal communication, organizational, and management skills
  • Training or equivalent experience in computer use and software, including Microsoft Word, Excel, PowerPoint, and Access
  • Minitab experience desirable


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