Engineer II, Quality

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 Quality Engineer II will be responsible for a variety of site Quality activities to ensure compliance with applicable quality objectives and regulatory requirements and will be located at our sites in Miami, FL. This role will report to the Manager, Quality.

Essential Duties & Responsibilities

• Direct efforts in risk identification and mitigation activities as part of evaluating site-related nonconformances, CAPAs, changes, or complaint investigations
• Support site teams in conducting investigations, including root cause analysis, corrections, corrective actions, preventive actions, and monitoring effectiveness
• Use of quality tools, such as 6Ms, 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Nonconformances: Coordinate quality review and approval of the site's nonconformances. Contribute with investigations and Root Cause Analysis, for the site.
• Evaluate, review, and coordinate QA approval of site-related investigations to ensure completion is appropriate to the level/ classification of the event
• Perform routine floor presence to ensure compliance with GMP, GTP, SOPs, and company procedures.
• Reinforce GMP, Quality System, and compliance expectations through coaching and floor interactions.
• Act as a key quality resource for the site, driving a culture of quality, continuous improvement, and adherence to the One Team mindset
• Review of incoming inspection results, certificates of analysis (CoA), and supplier documentation to confirm materials meet defined specifications and regulatory requirements
• Change Controls: Support initiation, evaluation, and completion of changes impacting the site to ensure timely and satisfactory implementation of changes by all departments at the site. Review and approve site-specific protocols and reports as part of changes
• CAPA program: Support and monitor all CAPAs related to the site to ensure implementation is completed according to the established procedures and policies
• Provide site QMS metrics information to the QMS team in support of Quality Management Review
• Support Internal Audits as requested by management
• Collaborate with cross-functional departments to ensure timely implementation of quality systems
• Other Duties as assigned

Skills & Abilities

Essential Duty Definition:

• Working knowledge of electronic Quality Management Systems
• Working knowledge and ability to apply GTP's and GMP's in conformance to U.S. standards
• Ability to effectively negotiate and build collaboration amongst individuals
• Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for ERP and Quality Management Systems

Position Expertise/Qualifications

• BS in Engineering or BSE in biological sciences or related field
• 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree

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 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.