Quality Supervisor - Kitting, Warehousing & Distribution

About the role

As Quality Supervisor, you will be the primary quality authority at our diagnostic kitting and distribution facility. This hands-on position involves developing and managing the daily quality system for a site that assembles medical device components into patient-ready blood collection kits. You will ensure the highest quality standards are met for products shipped to patients and specimens returned for diagnostic analysis.

Key facts

What you'll do

• Establish and maintain quality requirements for storing components and finished kits, including environmental controls and expiry management (FEFO).
• Oversee warehouse monitoring, ensuring equipment calibration and conducting regular audits for proper product segregation and identification.
• Develop and maintain incoming inspection procedures for all kit components, verifying shipments against purchase orders and supplier documentation.
• Make disposition decisions for incoming lots and manage the nonconformance process for out-of-spec materials, maintaining full forward and backward traceability.
• Support operations by creating SOPs, work instructions, and batch records for kit assembly, performing in-process inspections and line walks.
• Review completed kitting records for accuracy and completeness, ensuring correct and controlled kit labeling.
• Manage the change control process for any modifications to kit components, labels, or instructions.
• Own and execute customer quality complaint evaluations and investigations, including root cause analysis for missing components, damage, or collection failures.
• Run the site's nonconformance and deviation process, conducting root cause analysis using structured tools and managing dispositions.
• Manage the Corrective and Preventive Action (CAPA) program, ensuring timely implementation, effectiveness verification, and recurrence prevention.
• Support operations training, manage training records and qualification matrices for all site personnel, and deliver refresher training as needed.
• Own and manage the document management process for SOPs, work instructions, forms, and specifications.
• Manage the change control process for any planned changes affecting kit quality or compliance.
• Plan and execute internal assessments across all site functions and support external audits as the on-site quality lead.
• Use quality data to identify and drive continuous improvement opportunities.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Quality Management, or a related field; or equivalent combination of education and directly relevant experience.
• 4-6 years of quality experience in a regulated medical device, IVD, or closely related healthcare manufacturing or distribution environment.
• Demonstrated experience writing and implementing SOPs, work instructions, and batch records.
• Hands-on experience running a nonconformance and CAPA system, including owning investigations.
• Strong written communication skills.
• Comfortable working in a fast-paced warehouse and kitting environment, managing competing priorities while maintaining compliance.

Practical notes

This is an on-site role requiring regular time on the warehouse and kitting floor, including standing, walking, and observing operations. Occasional lifting up to 30 lbs is required. Some schedule flexibility may be necessary to support operations across shifts or during audits and inspections. Benefits include unlimited PTO, company holidays, quarterly mental health days, comprehensive health benefits, parental leave, an Employee Stock Purchase Program (ESPP), 401k with employer matching, and offsite team retreats. We are committed to providing reasonable accommodations for qualified individuals with disabilities; please contact accommodations@forhims.com for assistance.