HMI Quality Control Supervisor

Company Overview

Hamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. Our focus is on developing ventilation technologies that prioritize safety, effectiveness, and lung protection. We are dedicated to easing the burden on healthcare professionals who work tirelessly every day, helping critically ill patients recover and regain their health.

We are committed to helping medical teams deliver the best respiratory care to anyone, anywhere.

Hamilton Medical, Inc. is seeking an experienced candidate to fill a Quality Control (QC) Supervisor position. This role provides oversight and leadership to the Quality Control Technicians and ensures our raw materials and finished products meet specifications and customer requirements. The position is responsible for leading, coaching, and supervising the QC Technicians, including assigning tasks; prioritizing inspections to meet business needs;

identifying and correcting quality issues; resolving conflicts involving QC personnel; and ensuring all QC Technicians are adequately trained in the proper use of measurement devices and in documenting inspection data in a GMP environment. This position reports to the Director of Quality Assurance and Regulatory Affairs and is located in our Reno, NV manufacturing facility.

• Provide supervision and guidance to the QC Technicians who perform incoming material inspections, in-process inspections, and finished goods inspections.
• Ensure that all QC Technicians understand and are able to complete the following tasks:
  • Perform dimensional and visual inspections of various precision mechanical and electronic parts.
  • Utilize appropriate measurement tools for assigned tasks.
  • Generate and maintain inspection documents and files, clearly documenting inspection results, including resolutions and discrepancies.
  • Assist Engineers in identifying and troubleshooting discrepant materials.
• Provide clear and timely communication of ongoing quality issues and solutions to Quality and Operations Leadership.
• Collaborate with Operations and Engineering teams to ensure that drawings, specifications, and inspection requirements are clearly defined and documented.
• Oversee the creation of Nonconforming Material Reports (NCRs) in the eQMS system with accurate information and the closing of NCRs upon successful rework of product. Participate in Materials Review Board meetings by providing insight and information about nonconforming raw materials.
• Oversee the Calibration program for measurement tools and devices and ensure all measurement tools and devices utilized for quality decisions remain in good repair.
• Oversee the environmental controls for all controlled manufacturing environments, including bioburden testing, monitoring of environmental conditions, and documentation of housekeeping activities.
• Oversee the final release of medical devices that meet all specifications and requirements.
• Oversee the collection, organization, and filing of quality inspection records and Device History Records (DHRs) to ensure compliance with regulations and procedures.
• Provide ongoing and annual feedback to all direct reports to ensure performance levels of team members is maintained.
• Other tasks and responsibilities as assigned by Leadership.

• Thorough knowledge of good manufacturing practices for medical products.
• Strong technical skills.
• Excellent knowledge of metrology and proper use of measurement tools and devices.
• Excellent communication and documentation skills.

• Bachelor's Degree in Engineering, Manufacturing Technology, Business, or related discipline from an accredited university.
• A minimum of 4 years of Quality Assurance or Quality Control experience.
• 1-2 years leading a team is preferred.
• Fluency in the English language required (both oral and written);
  German and any other language is an advantage.

• Excellent benefit package includes medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and more.
• Solid, stable, family-owned company.
• Must pass drug and background screens.
• May be required to wear Personal Protective Equipment (provided by employer).