Quality Engineer
Listed on 2026-06-18
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Engineering
Quality Engineering, Regulatory Compliance Specialist, Product 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.
- 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.
- 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.
- 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.
- 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.
- 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…
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