Quality Control & Inspection, Medical Device Packaging & Artwork (JP15885)

Location: Thousand Oaks, CA. 91320 (hybrid)

Employment Type: Contract Business Unit: Operations Duration: 1+ year (with likely extensions and/or conversion to permanent)3 Key Consulting is hiring an Artwork Quality Control & Human Factors Prototype Specialist – Combination Products for a consulting engagement with our direct client, a leading global biopharmaceutical company. We are looking for candidates with previous work involving fine motor skills and hands on experience. Relevant work experience, practical hobbies, and transferable skills are all valuable. If they have a portfolio of things they have built, that would be helpful. Local candidates are preferred. This Thousand Oaks (ATO)-based external worker provides independent quality control and inspection support for Instructional Design artwork deliverables and hands-on support for physical human factors and user research stimuli. The role helps ensure that files and study materials are complete, accurate, traceable, and ready for their next cross-functional review or process step. Instructional Design develops combination-product instructions for use, carton artwork, primary labels, and human factors study stimuli. This role provides the focused inspection and build capacity needed to help designers deliver accurate, high-quality work while maintaining pace across concurrent programs. The individual will work within established procedures and review tools, exercise judgment on routine issues, coordinate corrections with designers, and promptly escalate issues with potential quality, schedule, or cross-functional impact. Top Must Have Skills: Demonstrated ability to perform detailed visual and content inspections Ability to work onsite in our client in the Thousand Oaks (ATO) area on a regular basis Strong organization, attention to detail, manual dexterity, and ability to complete precise cutting, folding, gluing, labeling, and assembly tasks to a consistent standard Day to Day Responsibilities: Artwork quality control and inspection Perform detailed, independent internal quality control and inspection of Instructional Design files before distribution to cross-functional stakeholders or advancement to the next process step. Review labeling artwork files, including IFU, primary label, and carton, in accordance with SOP and associated requirements, approved references, and team procedures. Inspect artwork for content alignment, layout integrity, legibility, version control, illustration and callout accuracy, print-readiness considerations, and consistency with approved source content and design inputs. Document inspection observations clearly, route findings to the responsible designer, verify that requested corrections have been addressed, and maintain inspection records as required by the process. This role does not grant Quality-system or regulatory approval. Support continuous improvement of internal inspection checklists, job aids, and practical controls that reduce rework and prevent defects from reaching cross-functional review. Physical study stimuli build support Build and prepare physical study stimuli for Human Factors and Customer Experience activities, including printed IFUs, cartons, device labels, and assembled device or package and edit print-ready artwork and build files using Adobe InDesign, Adobe Illustrator, and comparable production software, following established file structure, approved artwork, and build instructions. Operate in-house production printers, including routine setup, material handling, print-quality checks, and basic troubleshooting; escalate equipment issues requiring technical service. Perform precise finishing work such as printing, trimming, cutting, folding, gluing, labeling, assembly, and final visual inspection to produce materials that accurately represent the intended study study materials, maintain clear identification and version control, and support efficient staging, packaging, receiving, and disposition of materials as assigned. Photograph and document completed study stimuli and final assembled configurations to support build traceability, version control, study records, and efficient future reconstruction. Provide responsive onsite support for compressed timelines and last-minute changes to study materials or build needs. Working relationships and operating expectations Partner closely with Instructional Design engineers and coordinate with Human Factors, Customer Insights, Artwork Center, Packaging Engineering, and other stakeholders as needed for assigned work. Follow documented processes, protect controlled and confidential materials, and maintain an organized, inspection-ready work area and file set. Manage assigned work with limited day-to-day supervision, communicate risks or dependencies early, and escalate non-routine issues to the Senior Manager or delegated lead.

Basic Qualifications: Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience Two to three years of demonstrated experience in a quality-controlled, process-driven environment, such as artwork production, labeling, packaging, print production, document control, manufacturing support, or a regulated industry. Demonstrated ability to perform detailed visual and content inspections, identify discrepancies, follow defined review criteria, and maintain accurate records. Ability to work onsite in the Thousand Oaks (ATO) area on a regular basis and to support time-sensitive physical build work when needed. Strong organization, attention to detail, manual dexterity, and ability to complete precise cutting, folding, gluing, labeling, and assembly tasks to a consistent standard. Clear written and verbal communication, sound judgment within defined processes, and the ability to manage multiple assigned tasks and changing priorities.

Preferred Qualifications: Experience with Adobe InDesign, Adobe Illustrator, Adobe Acrobat, or other comparable page-layout, artwork-production, prepress, or document-review software. Experience supporting pharmaceutical, medical-device, combination-product, consumer health, or other regulated artwork, labeling, packaging, or documentation activities. Familiarity with version-controlled files, inspection checklists, deviation or issue documentation, and controlled work instructions. Experience preparing mock-ups, prototypes, or study materials requiring careful physical assembly and quality checks. Scope and Decision Making: The role independently executes assigned inspection and stimuli-build work using established procedures, templates, and approved inputs. It may recommend practical improvements to tools and work practices. The role does not own requirements or evidence, regulatory strategy, labeling strategy, final artwork approval, or Quality-system approval. Red Flags: Previous Senior roles Lack of experience in quality systems or QA/QCNo examples of required build skills

Interview process: 2 phone interviews, 1 on-site/in-person at ATO We invite qualified candidates to send your resume to.