Sr. Quality Engineer, New Product Development

BioTissue Holdings Inc; Florida; On-site; USD 101,000 - 126,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401(k) Retirement Savings Plan

Paid Time Off

Tuition Reimbursement

Job summary

BioTissue Holdings Inc. in Miami, FL is seeking a Senior Quality Engineer for New Product Development.

You will lead quality planning, risk management, validation, and regulatory compliance across the product lifecycle from concept to commercialization. You will partner with R&D, Manufacturing, Regulatory Affairs, and Operations to ensure new products meet quality systems and customer expectations, drive design controls, and mentor junior engineers while supporting audits and continuous

Qualifications

• Bachelor’s degree in engineering, quality, life sciences, or related technical field.
• 10+ years in Quality Engineering with significant NPI/product development in medical device or pharma.
• Experience with medical devices or regulated industries.
• Knowledge of FDA, ISO 13485, ICH Q9, cGMP and related regulatory requirements.
• Experience with statistical analysis (sampling, SPC, DOE) and quality tools (QFD, QbD, CPV, Control Plan).
• Strong leadership, cross-functional collaboration and communication skills.

Responsibilities

• Lead quality activities for NPD projects from concept through commercialization.
• Serve as Quality representative on cross-functional NPI teams.
• Ensure compliance with regulations and internal QMS.
• Facilitate design control activities including design reviews and risk management.
• Mentor junior quality engineers and support audits.

Skills

Leadership

Project management

Risk management

Technical problem solving

Collaboration

Communication

Attention to detail

Education

Bachelor's degree in engineering

Advanced degree in Engineering/Quality

ASQ CQE certification

ASQ CRE certification

Tools

Statistical analysis

QFD

DOE

Control Plan (CPV)

QbD

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Sr. Quality Engineer, New Product Development

Quality Full Time Engineering Miami, FL, US

2 days ago Requisition ID: 1723

Salary Range: $100,994.00 To $126,243.00 Annually

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.

• 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, 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.

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.