Quality Assurance (QA) Specialist

About Us

3DBioFibR Inc., founded in 2020, is a growing biotechnology company currently located in the heart of Halifax, Nova Scotia. Collagen fibers produced using our patented dry-spinning technology recapitulate the biomechanical and biochemical properties of natural collagen structures. With a fully automated manufacturing system, we are the first to produce collagen fibers at commercial scales for a variety of tissue engineering applications, including additives for 3D bioprinting and hydrogels, and cellular scaffolds for 2D and 3D cell and tissue culture.

Position Type

Full-time

Anticipated Start Date

August 10, 2026

About the Role

3DBioFibR is seeking a Quality Assurance (QA) Specialist to support the continued development and implementation of our Quality Management System (QMS) as we scale from development through manufacturing and commercialization. In this highly visible leadership role, you will be responsible for designing, maintaining, and continuously improving all aspects of our quality system to ensure compliance, operational excellence, and product integrity.

This is a hands-on, high-impact role within a fast-growing, mission-driven life sciences company. You’ll act as the single point of accountability for quality, partnering cross-functionally to embed quality into daily operations in a regulated environment. A bachelor’s degree in a scientific discipline is preferred; experience in life sciences and regulated manufacturing environments is required.

Responsibilities

Quality Management System Ownership and Compliance

• Own the implementation, maintenance, and continuous improvement of the company’s Quality Management System (QMS), including the electronic QMS (eQMS).
• Serve as the internal subject matter expert for quality standards and regulatory requirements for ISO 9001. Knowledge of ISO 13485 is considered an asset.
• Ensure company-wide compliance with applicable quality, regulatory, and internal requirements across R&D, manufacturing, and external partners.
• Establish and maintain document control systems, including SOPs, work instructions, forms, templates, and quality records.
• Lead management reviews, quality planning, and quality risk management activities.

Quality Assurance Operations

• Oversee quality review and approval of batch records, test data, and supporting documentation to ensure accuracy, traceability, and compliance.
• Lead all internal and external audits, inspections, and customer or partner assessments; act as the primary audit host.
• Own deviation management, non-conformance investigations, root cause analysis, and CAPA lifecycle management, ensuring timely and effective closure.
• Lead supplier qualification, monitoring, and re-evaluation activities, including quality agreements and supplier audits where required.

Leadership and Cross-Functional Collaboration

• Act as a trusted quality partner to R&D, manufacturing, operations, and leadership teams.
• Provide training, coaching, and guidance to staff on quality systems, procedures, and best practices.
• Champion a strong quality culture across the organization, balancing compliance with agility in a startup environment.
• Support quality-related interactions with customers, partners, and regulatory bodies as needed.

Continuous Improvement & Quality Metrics

• Define, track, and report quality KPIs to support data-driven decision-making.
• Identify systemic risks and opportunities for improvement within processes, documentation, and workflows.
• Lead continuous improvement initiatives to enhance compliance, efficiency, and scalability.
• Prepare quality documentation supporting audits, management reviews, partnerships, and commercialization activities.

Qualifications and Skills

• Bachelor’s degree in life sciences, or a related scientific discipline preferred.
• 3-5 years of quality assurance experience in a regulated environment; experience in biotechnology, medical devices, or life sciences strongly preferred.
• Demonstrated experience owning and maintaining a QMS, preferably within a growing or startup organization
• Strong working knowledge of ISO 9001 requirements. Knowledge of ISO 13485 requirements is considered an asset.
• Experience with electronic QMS platforms and controlled document management systems.
• Proven ability to lead audits, manage CAPAs, and drive quality system improvements.
• Excellent documentation, organizational, and prioritization skills.
• Strong written and verbal communication skills, with the ability to influence across functions.
• Comfortable operating with autonomy and accountability in a fast-paced, evolving environment.
• High level of integrity, sound judgment, and commitment to quality and continuous improvement.
• Previous experience in a decision-making role