Quality Supervisor — Kitting, Warehousing & Distribution

Hims & Hers • New Albany, OH

9d • Onsite

About The Position

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.

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 — not just contributing to investigations, but owning them.
• Strong written communication skills — quality in a regulated environment lives and dies on documentation quality.
• Comfortable working in a fast-paced warehouse and kitting environment, managing competing priorities without dropping the ball on compliance.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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-as-is, rework, reject, scrap) are appropriately justified and documented.
• Manage the CAPA (Corrective and Preventive Action) program: ensure that CAPAs are opened for significant or recurring issues, that corrective actions are practical and implemented on schedule, and that effectiveness is verified before CAPAs are closed.
• Prevent recurrence by translating CAPA outcomes into updated procedures, retraining, or process changes — and confirming those changes actually stick on the floor.
• Maintain the NC and CAPA register; present status and aging to site leadership on a regular cadence.
• Support the operations through ensuring appropriate training is performed
• Manage training records and a qualification matrix for all site personnel — tracking who is trained on which procedures and when retraining is due.
• Deliver refresher training when procedures change, when recurring errors indicate a gap, or when audit findings reveal a training deficiency.
• Own and manage document management process (e.g. SOPs, WI etc.): issue, revise, and retire SOPs, work instructions, forms, kitting record templates, and specifications in a controlled manner with appropriate review and approval.
• Manage the change control process for any planned change to a component, kit configuration, label, IFU, process, equipment, or facility that could affect kit quality or compliance.
• Ensure that obsolete documents are removed from the floor and that only current, approved versions are in use at all times.
• Plan and execute internal assessments across all site functions — receiving, kitting, warehousing, distribution, document control, training, complaints, and CAPAs — on a defined annual schedule.
• Provide clear findings to teams and collaborate to drive corrective actions.
• Support any external audits or inspections as the on-site quality lead; ensure records are organized and inspection-ready at all times.
• Use quality data — complaint trends, nonconformance rates, audit findings, CAPA aging — to identify improvement opportunities and drive them forward proactively.

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level