Quality Supervisor — Kitting, Warehousing & Distribution

About this role

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals.

ABOUT THE ROLE:

The Quality Supervisor leads all quality activities at the Hims & Hers diagnostic kitting and distribution facility. This is a hands-on role responsible for building and running the day-to-day quality system for a site that receives individual device components, assembles them into patient-ready blood collection kits, and ships those kits to patients based on prescriptions. Collected specimens are returned by patients to H&H Labs CLIA-certified laboratory for diagnostic analysis.

The right candidate is an experienced quality individual who has worked in a regulated medical device or IVD environment and knows how to write procedures, provide quality oversight of the operations, investigate problems, manage a nonconformance and CAPA process, support any change management activities for the operations and materials within the facility and build a quality culture on the floor — ensuring to meet and support building and distribution of quality products. This person will be the primary quality authority on-site and will own the quality program from the ground up.

YOU WILL:

Warehouse & Storage Controls

- Establish and maintain quality requirements for how components and finished kits are stored, including temperature, humidity, and environmental conditions appropriate for the materials (lancet devices, blood collection containers, bandages, printed collateral, and return shipping materials).

- Set up and manage expiry and shelf-life controls so that no expired or near-expiry product is assembled or shipped to patients — first-expiry/first-out (FEFO) compliance.

- Oversee monitoring for the warehouse and kitting areas as necessary; ensure monitoring equipment is calibrated and in-specification.

- Conduct periodic warehouse audits to verify that product is stored, identified, and segregated correctly, and that quarantine and hold areas are properly maintained.

- Manage the physical segregation and labeling of quarantined, rejected, and released inventory to prevent mix-ups or inadvertent use of non-conforming material.

Incoming Receipt & Component Inspection

- Write and maintain incoming inspection procedures for all kit components: lancet devices, blood collection containers, bandages, printed Instructions for Use (IFUs), return mailers, biohazard bags, and outer packaging.

- Verify that incoming shipments match purchase orders, are within specification, and are accompanied by appropriate supplier documentation (Certificate of Conformance, packing records).

- Make disposition decisions on incoming lots — accept, reject, or place on hold — and manage the nonconformance process when a supplier ships out-of-spec material.

- Maintain traceability records that link each component lot to the finished kit lots it was used in, supporting full forward and backward traceability.

- Support supplier quality performance over time; escalate recurring issues through formal corrective action requests.

Kitting Operations Quality

- Establish and support operations in the creation of applicable SOPs, work instructions, and batch records that govern kit assembly — covering component staging, assembly sequence, component quantity verification, label application, and final kit inspection, as applicable.

- Perform in-process inspections and line walks during kitting runs to verify that assemblers are following procedures, kits contain the correct components, and labels and IFUs are correct and legible.

- Periodically review completed kitting records for accuracy and completeness, confirm all in-process checks were completed, and ensure appropriate quality of kits for further distribution.

- Ensure kit labeling — including the outer box, IFU, and return shipping instructions — is correct, controlled, and issued in a way that prevents use of obsolete versions on the floor.

- Manage label and document change management process so that any change to a kit component, label, or IFU is reviewed, approved, and implemented in a controlled manner before it reaches production.

Kit Quality Complaints

- Own and execute customer quality complaint evaluations and investigations— including missing or wrong components, damaged packaging, unclear instructions, labeling errors, and any reports of patient injury or specimen collection failure.

- Conduct or oversee complaint investigations: gather facts, review kitting records and traceability data, determine cause, and document findings as appropriate.

- Track complaint trends over time and surface patterns to operations and leadership — using complaint data as a quality improvement input, not just a records-keeping exercise.

Deviations & Nonconformances

- Run the site's nonconformance (NC) and deviation process — from initial capture and documentation through investigation, disposition, and closure.

- Conduct root cause analysis for nonconformances using structured tools (5-Why, fishbone/Ishikawa, fault tree) and ensure that dispositions (use-

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