Sr. Quality Engineer, Product Development

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Quality Full Time Engineering Miami, FL, US

3 days ago Requisition

Salary Range: $ To $ Annually

About Bio Tissue & our Culture

At Bio Tissue, we transform the gift of life by sharing miracles. We are a diverse community, where talent and teamwork are core to who we are. Here, you are EMPOWERED to do the work you love, be yourself, and make an impact. Resilient and committed to our vision, we embrace challenges, celebrate courage, and take great pride in our work to create life-changing products.

Purpose led us here. Passion and legacy keep us going.

Position Summary

The Senior Quality Engineer, New Product Development/Introduction is responsible for leading quality planning, risk management, validation, and compliance activities throughout the product development and launch process. This role partners closely with R&D, Manufacturing, Supply Chain, Regulatory Affairs, and Operations to ensure new products are designed, validated, transferred, and commercialized in compliance with applicable quality system requirements and customer expectations.

• Lead quality activities for new product development and introduction projects from concept through commercialization.
• Serve as the Quality representative on cross-functional NPI teams.
• Ensure compliance with applicable regulations, standards, and internal quality system requirements.
• Facilitate design control activities, including design reviews, risk management, verification, validation, and design transfer.
• Lead and maintain risk management documentation, including DFMEA, PFMEA, hazard analyses, and risk-benefit assessments.
• Review and approve design history files, product specifications, protocols, reports, and engineering change documentation.
• Develop and execute quality plans supporting successful product launches.
• Partner with Manufacturing Engineering to support process development, process validation, test method development/validation, and production readiness
• Analyze quality metrics and trends to identify risks and drive continuous improvement.
• Support supplier qualification and supplier quality activities related to new product launches.
• Participate in material reviews, nonconformance investigations, CAPA activities, and root cause analyses.
• Ensure appropriate specifications, inspection, testing, and acceptance criteria are established for new products.
• Provide guidance and mentorship to junior quality engineers and project team members.
• Support internal, customer, and regulatory audits as subject matter expert for NPI quality processes.
• Drive implementation of best practices and lessons learned across product development programs.

Skills & Abilities

• Leadership and influence
• Project management
• Risk-based decision making
• Technical problem solving
• Collaboration and stakeholder management
• Effective communication and presentation skills
• Attention to detail and compliance focus

Required Qualifications

• Bachelor’s degree in engineering, Quality, Life Sciences, or related technical discipline.
• Minimum 10+ years of experience in Quality Engineering, with significant involvement in New Product Introduction and product development in the medical device, and/or pharmaceutical/Biologics industry
• Experience with medical devices, pharmaceuticals, biotechnology, or other highly regulated industries.
• Knowledge of FDA, QMSR/ISO 13485, ISO 14971, ICH Q9, cGMP, Validation Strategy in Medical Device/Pharmaceuticals and related regulatory requirements.
• Direct experience with statistical analysis (sampling plan, SPC, DOE, etc.) and quality engineering tools (QFD, QbD, CPV, Control Plan,…