Sr. Quality Engineer, New Product Development

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.