Director, Quality

How You’ll Contribute:

• Design, establish, implement and maintain Elutia’s quality systems to comply with regulatory requirements, including Quality System (QSR) Regulation (21 CFR part 820) for Medical Devices, required provisions from drug current Good Manufacturing Practice (21 CFR Part 211) in accordance with 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach) for combination drug-device products, 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue Products, and ISO 13485, as applicable to Elutia Inc. business requirements.
• Provide leadership in the qualification of new products and processes including facility and equipment qualification, process qualification, packaging development and qualification, sterilization validation, and product stability programs.
• Provide leadership in Design Control, leading development of the Design History File (DHF), Device Master Record (DMR), Failure Modes and Effects Analysis (FMEA), and Verification and Validation (V&V).
• Provide leadership in conducting product Design Verification testing, biocompatibility assessments, product/process qualifications and validation activities in establishing safety and efficacy of developed products including risk management profiles for Elutia products.
• Hire, manage, train and develop the talents and capabilities of Quality organization.
• Lead or participate on multidisciplinary teams for new product development and/or to resolve complex product investigations. Author, review, and approve procedures, specifications, policies, and quality plans to support the launch of a new manufacturing site and two new manufacturing processes.
• Manage, interact, and communicate with FDA, notified bodies, and regulators during on-site audits / inspections, field actions, recalls, or post market surveillance/vigilance activities.
• Update Executive Management on the performance of the quality system and any need for improvement using established metrics and reports.
• Manage/oversee responsibilities for a robust Quality Management System, including Document Control, Quality Assurance, Supplier Management, Production and Process Controls, Investigations and CAPAs, Complaints, Post-Market Surveillance programs, Quality Planning and Quality Metrics.

What You’ll Bring: 

• Minimum of 10 years of experience in a Quality Management role
• Extensive quality experience in a FDA and ISO regulated environment, with specific knowledge of Quality System (QSR) Regulation (21 CFR part 820) for Medical Devices, required provisions from drug current Good Manufacturing Practice (21 CFR Part 211) in accordance with 21 CFR 4.4(b)(2) (device QS regulation-based streamlined approach) for combination drug-device products, and ISO 13485. Knowledge of 21 CFR Part 1271 for Human Cells, Tissues, and Cellular and Tissue Products is ideal but not required.
• Significant experience in the healthcare industry (medical device, and/or combination products), both in Operational / Manufacturing and R&D/Product development environments.
• Demonstrated capability in business process/system management and improvement.
• Experience interfacing with government and accreditation agencies (FDA, ISO, Notified Bodies), managing audits and supporting regulatory filings, responses and other documents required in a regulated environment.
• Strong leadership skills; demonstrated ability to clearly develop and articulate short-term goals and objectives to drive performance and results.
• Experience writing and reviewing Quality System documents. The person in this role will be expected to take a hands-on role bring up the facility and manufacturing processes.
• Experience working in a lean team environment, balancing multiple priorities.
• Experience working with tight timelines, ensuring that project deadlines are met without impacting quality.
• Must embrace our CRU values- contagiously confident, ridiculously relentless, unanimously united.
• ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred.