Quality Engineer

About the Role We are seeking a strategic, analytical, and collaborative Quality Engineer to join our Product Quality Team. This high‑impact role will champion consumer safety, device efficacy, and regulatory‑aligned quality throughout the product lifecycle, ensuring that every product delivers a trustworthy, high‑performance skincare experience. You will collaborate cross‑functionally with R&D, Human Factors, Clinical/Scientific Affairs, Industrial Design, Supply Chain, Manufacturing, Customer Experience, Marketing, and Executive Leadership to shape skincare devices that not only meet specifications but consistently exceed user expectations – pre‑ and post‑launch. This is an exceptional opportunity to influence device design, quality strategy, and consumer satisfaction at scale, while gaining exposure to executive‑level decision‑making and innovation initiatives across the company. Key Responsibilities Analyze consumer complaints, device returns, skin‑interaction feedback, clinical testing outcomes, and post‑market surveillance data to identify root causes and drive both technical and user‑experience corrective actions. Act as the voice of the consumer and patient in product quality forums, ensuring clinical insights, feedback, and user safety concerns lead to meaningful device improvements. Lead structured problem‑solving. Product Development Support Serve on NPD Quality for device programs, providing input into design controls, safety assessments, human factors reviews, and documentation from early concept through verification, validation, and launch. Provide quality input on Engineering Change Notices (ECNs), ensuring robust verification/validation and safeguarding device performance, safety, and claim integrity. Partner with R&D, Clinical/Scientific Affairs, and Product Development to define, measure, and validate critical‑to‑quality attributes such as skin compatibility, thermal/electrical safety, treatment efficacy, and reliability. Ensure biocompatibility considerations, labeling requirements, and claims substantiation are integrated into the product development lifecycle. Process & Supplier Quality Integration Collaborate with suppliers on root cause investigations and ensure timely and compliant closure of corrective and preventive actions (CAPAs) – especially for contact materials, energy‑based components, and precision hardware elements. Influence manufacturing readiness by identifying device‑specific failure modes (e.g., thermal drift, optical degradation, vibration consistency, firmware/hardware interaction issues) and recommending risk‑reducing controls. Support production transfer activities by ensuring alignment between design intent, process capability, and device quality requirements. Post‑Launch & Lifecycle Quality Management Monitor macro‑level product performance trends, consumer sentiment, and post‑market surveillance indicators to identify early warning signals for skincare‑specific risks (e.g., irritation reports, thermal anomalies, inconsistent treatment outcomes). Drive iterative improvements to both hardware and user‑experience elements post‑launch, collaborating with Engineering, Design, and Quality partners. Own product health dashboards and deliver actionable insights to senior leadership – emphasizing device safety, reliability, and real‑world efficacy. Cross‑Functional Influence & Continuous Improvement Help facilitate cross‑functional quality meetings, delegate issue resolution, and ensure clear ownership and accountability across engineering, supply chain, and other teams. Identify and implement process efficiencies within design control workflows, documentation management, risk files, and testing strategies. Coach junior engineers or quality team members to elevate the rigor, technical depth, and compliance mindset of the overall Quality function. Qualifications Education & Experience Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Quality Engineering, Product Development, Human Factors Engineering, or a related technical discipline. 1-2 years of experience in quality engineering with a strong focus on new product development. Experience working with risk management, verification/validation, and design controls in a regulated or semi‑regulated device environment. Technical Skills & Knowledge Deep understanding of medical‑device‑relevant product development lifecycle, risk management, design control, and verification/validation requirements. Proficient with root cause analysis tools (5 Whys, Fishbone, Fault Tree), FMEA, and statistical analysis. Strong knowledge of change management, CAPA processes, manufacturing quality, engineering documentation, and control methodologies. Working knowledge of standards such as ISO 9001, ISO 13485, IEC/UL device safety standards, ISO 14971 (Risk Management), and human factors guidelines is highly preferred. Tools & Systems Proficient in Microsoft Office Suite; experience with PLM platforms, quality systems, and eQMS tools is a plus. Soft Skills Strong problem‑solving mindset, attention to detail, and structured analytical approach. Excellent written and verbal communication skills with the ability to influence technical and non‑technical stakeholders and present to leadership. High degree of autonomy, initiative, accountability, and follow‑through in driving cross‑functional programs to completion. Compensation The annual salary range for this position is $83,500 – $149,500 USD. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate. Benefits Medical insurance, dental insurance, vision insurance, flexible spending accounts, health savings accounts with company contribution, 401(k) retirement plan with matching, employee stock purchase program, life insurance, AD&D, short‑term disability insurance, long‑term disability insurance, generous paid time off, company holidays, parental leave, identity theft protection, pet insurance, pre‑paid legal insurance, backup child and elder care days, product discounts, referral bonus program, and more. Equal Employment Opportunity We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, disability, or any other class protected by legislation, and local law. SharkNinja will consider reasonable accommodations consistent with legislation, and local law. If you require a reasonable accommodation to participate in the job application or interview process, please contact SharkNinja People & Culture at View email address on click.appcast.io. #J-18808-Ljbffr Ninjakitchen