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Added 9 mins ago
Controls Engineer
FXI
Radnor, PA
Job Overview: We are currently hiring a Controls Engineer to join our operations team. In this position you will provide electrical and controls support. You will provide directions for…
Added 32 mins ago
Systems Engineer Enterprise Search
AutoZone
Memphis, TN
Develop and enhance e-commerce search capabilities using Elasticsearch, contributing to the design, implementation, and ongoing improvement of search functionality.
Added 44 mins ago
GCP Cloud Analytics Engineer
Deloitte US
Atlanta, GA · Baltimore, MD · Boston, MA · Charlotte, NC · Chicago, IL · Cincinnati, OH · Cleveland, OH · Columbus, OH · Costa Mesa, CA · Dallas, TX · Denver, CO · Detroit, MI · Houston, TX · Indianapolis, IN · Kansas City, MO · Los Angeles, CA · McLean, VA · Miami, FL · Minneapolis, MN · Morristown, NJ · NY · Philadelphia, PA · Pittsburgh, PA · Rosslyn, VA · Sacramento, CA · San Diego, CA · San Francisco, CA · San Jose, CA · Seattle, WA · St. Louis, MO · Stamford, CT · Tampa, FL · Tempe, AZ
…a Sr Consultant, GCP Cloud Analytics, you will help clients design, build, and scale Google Cloud Platform-enabled data ecosystems that support enterprise decision-making, analytics, and…
Added 45 mins ago
OneStream Lead Analytics and Insights Engineer II Manager
Deloitte US
Atlanta, GA · Baltimore, MD · Boston, MA · Charlotte, NC · Chicago, IL · Costa Mesa, CA · Dallas, TX · Denver, CO · Detroit, MI · Fort Worth, TX · Fresno, CA · Hartford, CT · Honolulu, HI · Houston, TX · Huntsville, AL · Jericho, NY · Jersey City, NJ · Las Vegas, NV · Los Angeles, CA · McLean, VA · Miami, FL · Milwaukee, WI · Morristown, NJ · NY · Philadelphia, PA · Portland, OR · Princeton, NJ · Raleigh, NC · Richmond, VA · Rosslyn, VA · Sacramento, CA · San Diego, CA · San Francisco, CA · San Jose, CA · Seattle, WA · Stamford, CT · Washington, DC · Westlake, TX
Lead the design and implementation of OneStream solutions for financial consolidation, planning, budgeting, and reporting
Added 1 hour ago
Manufacturing Engineer
Komatsu
Chattanooga, TN
Own, develop, and continuously improve large assembly processes for heavy equipment at CMO. The Manufacturing Engineer translates product and production requirements into safe, repeatable,…
Added 1 hour ago
Lead Instrumentation & Controls Engineer 1 - Nuclear
Sargent & Lundy
UNAVAILABLE, OH
Develop Digital Systems Design -- PLC, DCS, HSI, networked computer systems.
Added 1 hour ago
Senior Electrical Engineer 1 - Nuclear
Sargent & Lundy
UNAVAILABLE, OH
…environment with other engineers and designers involved in the design, modification, and analysis of new and existing nuclear power plant electrical…
Added 1 hour ago
Lead Instrumentation & Controls Engineer 1 - Nuclear
Sargent & Lundy
Perry, OH
Develop Digital Systems Design -- PLC, DCS, HSI, networked computer systems.
Added 1 hour ago
Senior Electrical Engineer 1 - Nuclear
Sargent & Lundy
Perry, OH
…environment with other engineers and designers involved in the design, modification, and analysis of new and existing nuclear power plant electrical…
Added 1 hour ago
Senior Electrical Engineer 1 - Nuclear
Sargent & Lundy
Chicago, IL
…environment with other engineers and designers involved in the design, modification, and analysis of new and existing nuclear power plant electrical…
Added 1 hour ago
Automation & Control Systems Engineering Consultant 2 - Mission Critical
Sargent & Lundy
United States
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 2 - Mission Critical
Sargent & Lundy
Warrenville, IL
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 2 - Mission Critical
Sargent & Lundy
Atlanta, GA
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 2 - Mission Critical
Sargent & Lundy
Augusta, GA
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 1 - Mission Critical
Sargent & Lundy
Warrenville, IL
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 1 - Mission Critical
Sargent & Lundy
Atlanta, GA
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Automation & Control Systems Engineer 1 - Mission Critical
Sargent & Lundy
Augusta, GA
Prepare specifications and design media for the procurement and implementation of software, instrumentation, and control system platforms
Added 1 hour ago
Lead Network Engineer 1 - Nuclear
Sargent & Lundy
Warrenville, IL
…need for additional I&C Engineers.This position requires an engineer who has expertise in digital system network design. Responsibilities will include, but are not limited…
Added 2 hours ago
Engineer, Clinical
The General Hospital Corporation
United States
The clinical engineer provides engineering services to medical and research areas including selection, acquisition, service of medical devices, and project management. Performs technical…
Added 2 hours ago
C
ASIC DFT Engineer I (Full Time) - United States
Cisco
San Jose, CA · RTP, NC · Allentown, PA
- Full-time
You will be in the Silicon One development organization as an ASIC Design for Test Engineer with a primary focus on Design-for-Test. You will work with frontend RTL teams, backend Physical…
Added 3 hours ago
DevSecOps Engineer
SAIC
Remote, United States
…and be a critical subject matter expert for consulting and implementation support across the VA Medical Disability Exam (MDE) program. This essential program provides Veterans with timely,…
Added 3 hours ago
Project Engineer
American Bridge Company
Seattle, WA
Position: Project Engineer – Major Bridge Rehabilitation
Added 3 hours ago
Senior Structural Engineer
The Misch Group
Dallas, TX
We are seeking a seasoned and accomplished Senior Structural Engineer to join our esteemed team. As a Senior Engineer, you will play a pivotal role in shaping and executing the design of…
Added 3 hours ago
Civil Engineer In Training
The Misch Group
Valley View, OH
Position Overview: The Engineer in Training (EIT) will support the design, analysis, and implementation of various engineering projects while working under the guidance of experienced…
Added 3 hours ago
Construction Superintendent
Optimum Energy Co LLC
Rockdale, TX
…and serves as the primary field representative to the owner, design team, and project partners. The Superintendent owns site safety, sequencing, quality, productivity, and closeout, and…

BioTissue Holdings Inc

Sr. Quality Engineer, New Product Development

Miami, FL, United States

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Job details

Posting language: English
Posted: Nov 6, 2026

Original job description

About BioTissue & our Culture At BioTissue, 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.

Essential Duties & Responsibilities

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
Continuous improvement mindset
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, etc.).
Strong knowledge of quality systems, risk management, validation, and design control methodologies.
Experience leading cross-functional projects in regulated manufacturing environments.
Demonstrated expertise in root cause analysis and continuous improvement tools.
Strong analytical, problem-solving, and communication skills.
Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications

Advanced degree in Engineering, Quality, or related field.
ASQ Certified Quality Engineer (CQE) or equivalent professional certification.
ASQ Certified Risk Reliability Engineer (CRE) or equivalent professional certification

Physical Requirements

Sedentary work that generally requires sitting and/or standing

Total Rewards At BioTissue, we believe our people are our greatest asset. We offer a comprehensive Total Rewards package designed to support employees' health, financial wellbeing, professional growth, and work-life balance.

Our benefits may include:

Medical, Dental, and Vision Insurance
Health Savings Account (HSA) and Flexible Spending Accounts (FSA)
401(k) Retirement Savings Plan
Company-Paid Basic Life and AD&D Insurance
Voluntary Life and AD&D Insurance
Short-Term and Long-Term Disability Coverage
Employee Assistance Program (EAP)
Legal and Identity Protection Benefits
Pet Insurance
Paid Time Off and Company Holidays
Paid Parental and Birthing Leave
Family and Medical Leave (FMLA), where applicable
Tuition Reimbursement and Professional Development Support
Performance-Based Incentive Opportunities
Equity or Stock Programs, where applicable
Benefits of eligibility and offerings may vary based on position, location, and employment status.

ADA Statement BioTissue is committed to providing reasonable accommodations to qualified individuals with disabilities throughout the hiring process and employment lifecycle. If you require assistance or accommodation to participate in the application process or perform the essential functions of a position, please contact us to discuss your needs.

Qualified applicants with disabilities will be considered for employment and may be eligible to perform the essential functions of the position with or without reasonable accommodation.

Equal Employment Opportunity BioTissue is committed to fostering a workplace where everyone feels valued, respected, and empowered to contribute. We welcome applicants from diverse backgrounds and experiences and are proud to be an Equal Opportunity Employer. Employment decisions are based on qualifications, merit, and business needs, without regard to any legally protected characteristic.

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More about this job

Skills

Risk management
Regulatory compliance
Supply chain management
Regulatory affairs
Documentation
Process improvement
Inspection
Leadership
Project management
Decision making
Problem solving
Collaboration
Stakeholder management
Communication skills
Presentation skills
Attention to detail
Medical devices
Biotechnology
Statistics
SPC
Quality control systems
Root cause analysis

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