Quality Assurance Inspector II

3 weeks ago

Clarion, Iowa, United States Sonendo, Inc. Full time

Key Responsibilities:

  • Oversee the evaluation and approval of incoming raw materials, finished goods, and final assembly inspections, ensuring compliance with quality standards. Additionally, manage the calibration of all equipment utilized in manufacturing and quality assessments.
  • Examine incoming raw materials for shipment accuracy, documentation correctness, and part acceptability.
  • Conduct thorough reviews of Finished Goods and Device History.
  • Adhere to all safety protocols.
  • Implement Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Document all transactions to maintain precise inventory records.
  • Organize the quarantine area to clearly label all non-conforming, rejected materials, and items pending inspection.
  • Ensure proper segregation of sterile and non-sterile products.
  • Maintain and organize paper files to ensure they are accurate and complete.
  • Prioritize inspections based on guidance from supervisors and the demands of production and product development.
  • Assist Quality Management in conducting quality reviews and audits.
  • Ensure timely calibration of necessary items and complete records and documentation in accordance with standard operating procedures (SOP).
  • Perform additional duties as assigned by supervisors.
  • Maintain adherence to Quality System procedures and company policies.

Qualifications:

  • Experience with vision systems, micrometers, calipers, and other inspection tools to verify dimensional accuracy according to specifications.
  • Strong understanding of fundamental metrology practices and principles.
  • Exceptional attention to detail.
  • Effective oral and written communication skills.
  • Ability to interpret and understand technical drawings.
  • Capability to follow instructions accurately.
  • Visual acuity to differentiate colors and identify non-conforming parts.
  • Proficiency in using Windows PC and Microsoft Office applications.
  • Familiarity with GMP and ISO quality systems.
  • Ability to work independently and complete assignments within established guidelines.
  • Experience initiating Document Change Orders for Receiving Inspection Forms and Procedures.
  • 2 to 5 years of experience in quality and/or visual inspections.
  • High school diploma or GED required; Associate degree preferred.

Physical Requirements:

  • Primarily sedentary position, with extended periods of sitting required.
  • Frequent standing, walking, and meeting activities throughout the workday.
  • Ability to process paperwork and utilize office equipment, including personal computers and copiers.
  • Significant portion of the day spent communicating verbally in person and via phone.
  • Normal or corrected vision required for reading documents and using computer terminals.
  • Ability to perform essential job functions in compliance with ADA, FMLA, and other applicable standards.
  • Regular, punctual attendance is necessary.
  • Capability to lift and carry up to 50 lbs.
  • Clear communication skills for effective telephone conversations.

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