Director of Quality Engineering - Osteal Therapeutics

Osteal Therapeutics, Inc. (Osteal) is a late clinical-stage biopharmaceutical company developing a novel pipeline of combination product therapeutics for musculoskeletal infections and their consequences. Our lead investigational candidate, VT-X7 was granted Breakthrough Therapy, Orphan Disease, FastTrack and Qualified Infectious Disease Product designations by the US Food and Drug Administration and is rapidly completing its clinical trial program for the treatment of Periprosthetic Joint Infection (PJI) with launch expected in 2025. A robust pipeline of additional indications and therapeutic candidates will lead to rapid and sustained growth for the foreseeable future.

Job Title: Director of Quality Engineering

Job Status: Full Time Exempt

Reports to: VP of Quality Assurance

Amount of Travel Required: up to 15%

Location: Dallas, TX

Work Schedule: Full-time

Positions Supervised: Up to 5

The Director of Quality Engineering is responsible for developing, implementing, and overseeing Quality Engineering programs to ensure compliance with regulatory requirements in a face-paced drug/device combination product organization. Reporting directly to the VP of Quality Assurance, the Director of Quality Engineering will oversee processes related to Quality Engineering during design and development, product manufacturing, and in the post-market stage. This role requires leadership in managing a team that collaborates cross-functionally, technical expertise in medical device development and testing, and a deep understanding of regulatory requirements for medical devices, including software.

Essential functions of the position include but are not limited to the following. Other duties may be assigned.

·Lead and mentor a team of Quality Engineers to ensure that products are developed, manufactured, and distributed in accordance with regulatory requirements and standards, and internal quality system requirements.

·Drive the development and execution of quality strategies to support business objectives, improve product quality, and maintain compliance.

·Ensure compliance with applicable regulatory requirements during all stages of the product life cycle and during maintenance of the Quality Management System.

·Assist VP of Quality Assurance in overseeing internal and external audits and manage any follow-up actions for findings and/or nonconformances.

·Ensure that design history files (DHF) and technical documentation are complete, accurate, and compliant with applicable regulations.

·Collaborate with Regulatory Affairs to ensure that product submissions meet regulatory requirements.

·Collaborate with R&D, Manufacturing, and other departments to ensure quality is integrated into the design and development process, including but not limited to general Design Controls requirements, Risk Management, and Verification & Validation (V&V) activities.

·Review and approve design inputs, design outputs, design verification and validation plans/reports, and design transfer activities.

·Participate in design reviews, ensuring that design risks are identified, assessed, and mitigated appropriately.

·Provide input on product and process development to ensure manufacturability, reliability, and compliance with quality standards.

·Provide oversight to supplier quality processes, including qualification, audits, and performance monitoring to ensure consistent delivery of high-quality products.

·Work closely with suppliers to resolve quality issues ad implement corrective and preventive actions.

·Provide oversight of risk management activities, including creation and maintenance of risk management files in accordance with ISO 14971.

·Conduct Failure Mode and Effects Analysis (FMEA) and other risk assessment tools to identify potential risks and develop mitigation strategies.

·Ensure that risk management activities are integrated into the design control process and are continuously monitored throughout the product lifecycle

·Oversee quality support for contract manufacturing, including but not limited to process validation, in-process testing, and final product release.

·Collaborate with internal and contract manufacturer production teams to ensure product quality and resolve quality-related issues in a timely manner.

·Identify and implement opportunities for continuous improvement in quality processes and practices.

·Lead or participate in cross-functional teams to drive quality improvements and operational efficiencies.

·Monitor and analyze quality metrics related to design and development, supplier quality, and post-market quality assurance activities.

·Minimum of B.S. degree in mechanical or biomedical engineering, or related field (M.S. or Ph.D. preferred).

·Minimum of 10 years of experience in Quality Engineering or Quality Management in the medical device industry, with at least 5 years in a management role.

·Experience in product development under design controls, process validation, risk management, and supplier quality.

·Proven track record in brainstorming, ideation, and conceptual design.

·Hands-on technical skills for graphic presentation of ideas, prototyping, and testing.

·Experience working with contract manufacturers and managing those relationships.

·Comprehensive understanding of FDA GMP regulations and standards applicable to medical device quality systems and product development including but not limited to 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, ISO 11607, and ISO 10993-1.

·Excellent organizational and communication skills.

·Effective at working independently with minimal direction and within project teams.

·Ability to manage multiple priorities for self and teams.

·Excellent organizational and communication skills.

·Hands-on, driven work ethic and entrepreneurial spirit.

·Willing and able to travel occasionally for project-related meetings and supplier visits (typically less than 15%).

·Proficient in MS Office, Smartsheet, and general business software applications.

·Experience working in electronic Quality Management Systems.

If you have the required skills and qualifications, we invite you to apply and join our team dedicated to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.