Bachelor's degree in engineering, Quality, Life Sciences, or related technical discipline.
10+ years of experience in Quality Engineering, particularly in New Product Introduction within regulated industries.
Experience with medical devices, pharmaceuticals, or biotechnology.
Knowledge of FDA regulations and ISO standards relevant to quality management.
Direct experience with statistical analysis and quality engineering tools.
Strong understanding of risk management and validation methodologies.
Proven ability to lead cross-functional projects in regulated environments.
Responsibilities
Lead quality activities for new product development from concept to commercialization.
Serve as the Quality representative on cross-functional NPI teams.
Ensure compliance with regulations and internal quality requirements.
Facilitate design control activities including risk management and validation.
Maintain risk management documentation such as DFMEA and PFMEA.
Review and approve design history files and product specifications.
Analyze quality metrics to identify risks and drive continuous improvement.
Benefits
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
Short-Term and Long-Term Disability Coverage
Employee Assistance Program (EAP)
Tuition Reimbursement and Professional Development Support
Full Job Description
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.
