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Lead Quality Assurance Technician

2 months ago

Clarion, Iowa, United States Sonendo Full time
Overview

Sonendo is a pioneering medical technology firm dedicated to revolutionizing dentistry through innovative sound science. We are in the process of assembling a high-performance team that values creativity and innovation, committed to collaboration and integrity. Our success hinges on developing groundbreaking technologies, and we aim for excellence in our products and services by attracting dynamic, entrepreneurial individuals who share this vision.

Key Responsibilities

Accountable for the inspection and approval of incoming raw materials, finished goods, and the final assessment of assemblies and post-sterilization products. Additionally, ensures the calibration of all instruments utilized in manufacturing or quality decision-making.
  • Provide training and mentorship to Quality Control Inspectors
  • Assist in assigning the Daily Inspection Schedule
  • Participate in Daily Morning Production Meetings
  • Examine incoming raw materials, verifying shipment accuracy, documentation, and part acceptability
  • Identify and quarantine any non-conforming materials
  • Review Device History Records and work orders for accuracy and completeness
  • Cross-train in Cleanroom production processes
  • Cross-train in G3/G4 Console production
  • Ensure compliance with all safety protocols
  • Adhere to Good Manufacturing Practices
  • Document all transactions to maintain inventory accuracy
  • Manage the quarantine area to clearly label non-conforming, rejected materials and those awaiting inspection
  • Maintain separation of sterile and non-sterile products
  • Organize and ensure the accuracy of paper files
  • Prioritize inspections based on supervisory directives and manufacturing demands
  • Support Quality Management in conducting quality reviews and audits
  • Ensure timely calibration of items requiring it, completing records and documentation per Standard Operating Procedures
  • Complete Finished Goods and Device History Review Final Review
  • Compile and analyze laboratory performance metrics
  • Perform additional duties as assigned by supervisor
  • Maintain compliance with Quality System procedures and company policies
Qualifications
  • Minimum of 5 years of relevant experience in quality inspections
  • High school diploma or GED required
  • Associate degree preferred
  • Strong oral and written communication skills
  • Familiarity with fundamental metrology practices and principles
  • Ability to interpret and understand technical drawings
  • Capability to follow instructions and train new QC Inspectors on departmental procedures
  • Proficient knowledge of QAD and QCBD systems
  • Competence in using Windows PC and Microsoft Office applications
  • Understanding of GMP and ISO quality systems
  • Experience with vision systems, micrometers, calipers, and other inspection tools
  • Ability to work independently and complete assignments within established guidelines
  • Capability to initiate Document Change Orders for Receiving Inspection Forms and Procedures
Physical Requirements
  • Visual acuity to differentiate colors and identify non-conforming parts
  • Primarily sedentary position, with the need to sit for extended periods
  • Frequent standing, walking, and meeting activities throughout the workday
  • Ability to process paperwork and utilize office equipment (including personal computers, phones, copiers, etc.)
  • Significant portion of the day spent communicating verbally in person and by phone
  • Normal or corrected vision required for reading documents and using standard computer terminals
  • Ability to perform essential job functions in accordance with ADA, FMLA, and other federal, state, and local standards
  • Consistent regular and punctual attendance required
  • Ability to lift and carry up to 50 lbs
  • Ability to communicate clearly on the telephone
Compensation

We offer competitive pay. The base hourly rate is $30.00. Additional compensation and benefits may be available.

Additional Information

Sonendo provides a comprehensive benefits package and a collaborative, motivating work environment that encourages continuous innovation. Here, your contributions can significantly impact the organization's success.