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Quality Assurance Inspector II
2 months ago
Sonendo is a pioneering medical technology firm dedicated to revolutionizing dentistry through innovative sound science. We are in the process of assembling a dynamic team that values creativity and innovation, committed to collaboration and integrity. Our success hinges on the development of groundbreaking technologies, and we aim for excellence in our products and services by attracting energetic, entrepreneurial individuals who share this vision.
Responsibilities
The Quality Assurance Inspector II is accountable for the inspection and approval of incoming raw materials, finished goods, and the final examination of assemblies and post-sterilization products. Additionally, this role ensures the calibration of all tools utilized in manufacturing or quality decision-making.
- Conduct inspections of incoming raw materials, verifying shipment accuracy, documentation, and the acceptability of components.
- Complete reviews of Finished Goods and Device History.
- Adhere to all safety protocols.
- Comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Document all transactions to maintain inventory accuracy.
- Manage the quarantine area to ensure that all non-conforming, rejected materials, and items pending inspection are clearly labeled with their status.
- Ensure the separation of sterile and non-sterile products.
- Organize and maintain accurate paper files.
- Prioritize inspections based on supervisory directives and the demands of manufacturing and product development.
- Assist Quality Management in conducting quality reviews and audits.
- Ensure timely calibration of items requiring it and complete records and documentation per standard operating procedures (SOP).
- Perform additional duties as assigned by the supervisor.
- Maintain compliance with Quality System procedures and company policies.
- Experience with vision systems, micrometers, calipers, and other inspection tools to verify dimensional accuracy according to specifications.
- Knowledge of fundamental metrology practices and principles.
- Exceptional attention to detail.
- Strong oral and written communication skills.
- Ability to read and interpret technical drawings.
- Capability to follow instructions accurately.
- Visual acuity to distinguish colors and identify non-conforming parts.
- Proficiency in using Windows PC and Microsoft Office applications.
- Understanding of GMP and ISO quality systems.
- Ability to work independently and complete assignments within given parameters and accepted practices.
- Capability to initiate 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.
- This position is primarily sedentary, requiring the employee to sit for extended periods.
- Frequent standing, walking, and meeting activities are necessary throughout the workday.
- The employee must be able to process paperwork and utilize office equipment, including personal computers, phones, and copiers.
- A significant portion of the day involves oral communication in person and via phone.
- Normal sight or corrected vision is required to read documents and operate standard computer terminals.
- Ability to perform essential job functions consistent with ADA, FMLA, and other federal, state, and local standards, including meeting productivity standards.
- Regular, punctual attendance is required, consistent with ADA, FMLA, and other federal, state, and local standards.
- Must be able to lift and carry up to 50 lbs.
- Ability to communicate clearly on the telephone.
We offer competitive pay. The base hourly rate ranges around $30.00, with additional compensation and benefits potentially available.
Additional Information
Sonendo provides a competitive benefits package and a collaborative, motivating work environment that encourages continuous innovation. Here, your contributions will be valued, and your ideas can significantly impact the organization's success.