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Service Integration Lead (SIAM) - Federal Health IT
Rackner
Remote, United States
Work with service providers and operational teams to support consistent service management practices.
Added 1 min ago
CNC Machinist
Staff Management | SMX
Snoqualmie, WA
Join a team where craftsmanship, innovation, and quality truly matter. We are seeking an experienced CNC Machinist to support production, prototype, and R&D initiatives. In this role,…
Added 1 min ago
Material Handler
Staff Management | SMX
Leipsic, OH
…planned maintenance Adapt to work in various areas as needed to support…
Added 1 min ago
Dietary Lead
Vetter Senior Living
Kearney, NE
Lead and support daily dining services operations.
Added 1 min ago
Seasonal Retail Sales Associate-TOWN AND COUNTRY SHOPPING CE
Bath & Body Works
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No-cost mental health and well-being support through our Employee Assistance Program (EAP).
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Maintenance Technician I
Staff Management | SMX
West Chester, PA
Support problem solving, resolution of machine issues and reliability improvements
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Line Operator and Material Handler
Staff Management | SMX
Smyrna, TN
Actively participate the improvements proposal program
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AH
Travel MS/Tele Float Registered Nurse
Aya Healthcare
West Hollywood, CA
- $2,669 to $2,952 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel MS/Tele Float Registered Nurse
Aya Healthcare
West Hollywood, CA
- $2,669 to $2,952 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel PICU Registered Nurse
Aya Healthcare
Columbus, OH
- $2,790.32 to $3,028.28 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
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Travel Telemetry Registered Nurse
Aya Healthcare
Edgewood, KY
- $2,842.4 to $3,041.04 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
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AH
Travel ER Holding Registered Nurse
Aya Healthcare
Albuquerque, NM
- $2,851.68 to $3,054.48 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel ER Holding Registered Nurse
Aya Healthcare
Albuquerque, NM
- $2,851.68 to $3,054.48 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel Labor and Delivery Registered Nurse
Aya Healthcare
Tracy, CA
- $2,877.28 to $3,069.64 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
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AH
Travel CVOR Registered Nurse
Aya Healthcare
Anchorage, AK
- $2,844 to $3,083 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
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AH
Travel CVOR Registered Nurse
Aya Healthcare
Anchorage, AK
- $2,844 to $3,083 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
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Travel Cath Lab Registered Nurse
Aya Healthcare
Philadelphia, PA
- $2,897.4 to $3,098.2 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel Labor and Delivery Registered Nurse
Aya Healthcare
Tracy, CA
- $2,947.42 to $3,139.36 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel Labor and Delivery Registered Nurse
Aya Healthcare
Tracy, CA
- $2,947.42 to $3,139.36 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel ER Holding Registered Nurse
Aya Healthcare
Albuquerque, NM
- $2,964 to $3,180.28 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel ER Holding Registered Nurse
Aya Healthcare
Albuquerque, NM
- $2,964 to $3,180.28 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel PICU Registered Nurse
Aya Healthcare
Columbus, OH
- $2,968.52 to $3,206.12 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
AH
Travel PCU Registered Nurse
Aya Healthcare
Hays, KS
- $3,086.48 to $3,286.16 USD / week
A best-in-class support system and an exceptional experience. Enjoy accurate, weekly pay, and an entire team dedicated to your happiness on assignment, 24/7.
Added 2 mins ago
EHS Manager
Staff Management | SMX
St Louis, MO
Ensure compliance with OSHA Process Safety Management and EPA Risk Management Program guidelines, including facilitation and scheduling of Process Hazard Analyses, submittal of Risk…
Added 2 mins ago
Maintenance Technician
Staff Management | SMX
Cleveland, OH
…Maintenance Technician also contributes a wide range of maintenance support to their shift and on weekends with special emphasis on production lines and processing equipment. Pay rate is…

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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