Staff Quality EngineerMaclivaro Limited • Houston, TX, US
Staff Quality Engineer
Maclivaro Limited • Houston, TX, US
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job_description.job_card.job_descriptionEnsure compliance with FDA QSR, ISO 13485, and applicable global medical device regulations. Support inspection readiness and quality system robustness in preparation for FDA submission. Manage quality records including CAPAs, NCMRs, validation documentation, and audit responses. Lead or support process validation activities (IQ, OQ, PQ) for pilot and commercial-scale manufacturing. Analyze process capability and quality trends using statistical tools and drive improvements where needed. Partner with Operations to ensure smooth scale-up and transition to commercialization. Lead root cause investigations and implement effective corrective and preventive actions. Champion continuous improvement initiatives to strengthen quality culture and reduce non-conformances. Collaborate with cross-functional teams to resolve field issues or feedback from ongoing clinical use. Mentor junior quality engineers and foster a proactive, risk-based approach to quality. Influence cross-functional stakeholders to maintain a high bar for product safety and performance. Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related); Master's degree preferred. 5+ years of experience in quality engineering, ideally within the medical device industry. Experience supporting products through clinical trials, regulatory submission, or design transfer is highly desirable. Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and design control best practices. Proficiency with risk management tools (FMEA, FTA), statistical analysis (e.g., Minitab), and validation practices. Working knowledge of Six Sigma, Lean principles, and GDP (Good Documentation Practices). Excellent analytical, communication, and cross-functional collaboration skills. Comfortable in a fast-paced, high-growth environment with frequent cross-site interaction. Join a mission-driven team pioneering the future of minimally invasive surgery through advanced robotics. Contribute to a novel technology entering the final phases of development and regulatory approval. Be part of a company experiencing major growth with opportunities for professional advancement and impact.
This range is provided by Maclivaro Limited. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$140,000.00 / yr - $170,000.00 / yr
Direct message the job poster from Maclivaro Limited
Industry : Medical Devices / Surgical Robotics
Position Summary :
An exciting opportunity exists for a Staff Quality Engineer to join a rapidly growing medical robotics company developing a groundbreaking surgical system. The team is advancing toward FDA submission for their first-in-class product and is currently conducting clinical trials. As part of the Quality team, you'll play a key role in supporting regulatory approval, product reliability, and operational excellence during this pivotal phase of company growth.
Key Responsibilities :
Product Development & Design Quality
- Collaborate closely with R&D, Clinical, Regulatory, and Operations teams to ensure quality is embedded throughout the product development lifecycle.
- Support design verification, validation, and risk management activities as part of design control for a novel Class II / III medical device.
- Provide quality leadership through key product milestones, including regulatory submissions and market launch preparation.
- Develop and maintain comprehensive risk management files, including DFMEAs, PFMEAs, Fault Tree Analyses, Hazard Analyses, and Task Analyses, in accordance with ISO 14971.
- Ensure traceability of risk controls and alignment with usability and clinical data during ongoing trials.
Regulatory Compliance & Quality Systems
Manufacturing & Process Quality
Qualifications :
Why This Role?
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance, Engineering, and Manufacturing
Industries
Manufacturing, Medical Equipment Manufacturing, and Robotics Engineering
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