Posted 6 months ago  

Quality Assurance Manager at Hims & Hers - Hims, Inc

Posted 6 months ago - 123 views - 91 Applied

Hims & Hers is seeking an experienced Quality Assurance Manager who will have responsibility for creating and implementing quality standards for Hims products. The position will focus on driving continuous improvement efforts that benefit and delight the Hims customer. The QA Manager will provide support for and report to the Senior Quality Assurance Manager and will work with external manufacturers and suppliers to ensure products are produced to Hims standards.

Responsibilities:

  • Designs, develops, and implements a comprehensive quality assurance procedure to create and enforce a continuous improvement mindset at Hims
  • Prepares and analyzes product quality complaints and adverse reaction data to examine trends and estimate uncertain events using 7QC tools. Reports serious or repeated failures to manufacturers, recommends corrective actions, or employ programs for overall defect reduction in products to support customer satisfaction
  • In conjunction with Operations & Supply Chain Team members, reviews and approves manufacturing and assembly instructions for adequate points of inspection for manufacture, including receipt of incoming components; determines, develops and trains employees on appropriate inspection points at the warehouse using AQL inspection method techniques
  • Develops, implements, updates and strictly adheres to quality programs. Develops and reviews standards, policies, and procedures for all functions and departments involved with the production of all products. The Quality Assurance Manager has the ultimate authority and decision over the shipment of any product and accepts the responsibility for products being in compliance with all regulatory and company standards
  • Schedules and performs quality audits. Reports findings to the Manufacturer, the Hims Supply Chain & Operations Team. Uses fishbone analysis, six sigma & the 5S tools to develop corrective action plans & ensures timely resolution of findings. Acts as the onsite coordinator for any FDA audits
  • Ensures that all products manufactured meet regulatory and quality requirements in terms of testing, storage, and transportation
  • Provides expertise in critical quality areas for product launches including safety testing, pilot productions, product chemistry, packaging interactions, microbiology, and regulatory framework
  • Tracks and analyzes supplier key performance indicators (KPIs) and metrics to determine positive and negative trends in production, quality documentation, and research/technological capabilities to carry out annual supplier appraisals using TQRDCE models
  • Leads corporate risk management process through process mapping and FMEA methods. Ensures root cause and mitigation strategies are in place to identify and resolve quality events & incidences
  • Coordinates with internal team members in supplier selection, verification, and validation processes
  • Influences and collaborates with peers to ensure compliance with internal SOPs and FDA regulations. Maintains current knowledge of GMP Compliance programs and provides guidance on interpretation and application of specified QA/GMP compliance regulations, i.e.: 21 CFR Part 210/211
  • Provides cGMP training to Hims employees for adherence to regulatory and company protocols
  • Develops and implements annual quality plans, departmental goals, action plans, and budgets
  • Using creative thinking and design thinking methods, develops and constantly improves the quality process and procedures employed during the developmental and commercialization stages of Hims products
  • Drafts all testing protocols and acts as a liaison between the Hims team and the third-party testing labs

Experience & Skills:

  • 7+ years of quality assurance experience in Cosmetic, OTCs, Dietary Supplements, and Medical Devices
  • Ability to travel as needed approximately 25% of time
  • Energetic, highly self-motivated and able to work efficiently and productively in a rapidly-growing company
  • Strong ability to evaluate processes and to facilitate effective change
  • Excellent cross-functional collaboration, communication, and interpersonal skills
  • Strong project management skills
  • Ability to work independently to support quality goals
  • Proficiency in writing and oral presentations. Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook. MRP, Minitab experience is a plus
  • Knowledge and experience in auditing
  • Excellent skills in decision making, data collection and analysis, organizing, and planning
  • Ability to learn and apply QA tools such as Lean Six Sigma, SPC, Process Mapping, FMEA, and 5S.
  • BS in Chemistry or equivalent science field. Masters degree a plus
  • Quality certifications a plus

Hims is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. Hims considers all qualified applicants in accordance with the San Francisco Fair Chance Ordinance.