Summary
The Senior Quality Assurance Specialist is a senior individual contributor supporting quality and compliance for the organization’s biotech and in vitro diagnostic (IVD) products, with a primary focus on IVD/medical-device quality systems and design assurance. Working independently within established procedures and delegated authority, the Specialist administers and improves the electronic quality management system (eQMS), leads assigned quality investigations and corrective and preventive actions (CAPA), and supports audit and inspection readiness. The role coordinates technical documentation and design and development records with technical owners , develops documentation and eQMS training, and supports risk management, verification and validation, and continuous improvement. The Specialist escalates significant quality risks to the Director, Quality Assurance and Quality Systems and mentors colleagues without direct supervisory responsibility.
Essential Functions
- Quality Management System (QMS) Administration (approximately 15% of time)
- Technical File Management (approximately 20% of time)
- Training and Documentation (approximately 10% of time)
- Process Improvement (approximately 30% of time)
- Design and Development Quality Support (approximately 10% of time)
- Production, Supplier, and Post-Market Quality Support (approximately 15% of time)
Education and Experience
- Bachelor’s degree in Life Sciences, Engineering, or a related field. Advanced degree preferred.
- Minimum of 5 years of progressively responsible quality assurance experience within the biotech, IVD, or medical device industry, including independent ownership of quality system activities or cross-functional quality projects.
- Demonstrated practical experience applying ISO 13485:2016 and FDA Quality Management System Regulation (QMSR; 21 CFR Part 820), including quality records, CAPA, nonconformances, change control, and audit readiness.
- Hands-on experience administering and maintaining eQMS software, controlled document workflows, and training records; working knowledge of risk-based software validation, data integrity, and electronic records and electronic signature requirements under 21 CFR Part 11 where applicable.
- Familiarity with regulatory submissions, including EU IVDR and FDA requirements.
Skills and Competencies
- Strong understanding of quality management principles and regulatory requirements for biotech and IVD products.
- Proficiency in coordinating and reviewing technical files, including risk management and design documentation.
- Excellent organizational and project management skills.
- Strong communication skills with the ability to train and guide teams on quality documentation and compliance.
- Detail-oriented with a strong focus on accuracy and compliance.
- Problem-solving skills with a proactive approach to process improvement.
Knowledge and Skills – Preferred
- Practical experience applying ISO 14971 risk management principles, including hazard analysis, FMEAs, and verification of risk control effectiveness, preferred.
- Strong internal auditing skills.
- Direct experience with IVD technical documentation, EU IVDR requirements, and design and development records preferred.
- Experience independently planning and conducting internal audits preferred; ASQ Certified Quality Auditor, Certified Quality Engineer, or ISO 13485 lead auditor training preferred.
- Familiarity with CLSI guidelines for IVD analytical performance evaluation (e.g., precision, linearity, and detection capability) preferred.
Supervisory Responsibility
This position has no supervisory responsibility.
Work Environment
The work environment is primarily office-based with some exposure to laboratory and manufacturing settings. Laboratory and manufacturing areas may require the use of personal protective equipment (PPE) and adherence to biosafety and chemical safety procedures. Some laboratory experience is preferred.
Position Type/Expected Hours of Work
This position is onsite, full-time, Monday through Friday.
