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.

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.
• Coordinate quality review and approval of the site’s nonconformances; contribute to investigations and Root Cause Analysis
• 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 incoming inspection results, certificates of analysis (CoA), and supplier documentation to confirm materials meet defined specifications and regulatory requirements
• Support initiation, evaluation, and completion of changes impacting the site to ensure timely and satisfactory implementation by all departments; review and approve site-specific protocols and reports as part of changes
• Support and monitor all CAPAs related to the site to ensure implementation is completed according to 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

Requirements

• 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
• 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, PowerPoint, and other applications; familiarity with electronic systems for ERP and Quality Management Systems

Physical Requirements

Sedentary work that generally requires sitting and/or standing.

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
• 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.