Quality Systems Associate
Hopkinton, MA
Isto Biologics is a growing, 100% biologics-focused company committed to helping patients heal faster by providing a range of advanced solutions to surgeons of varying specialties. Isto is seeking a full-time Quality Systems Associate to join their Quality team.
The Quality Assurance Associate is responsible for supporting and maintaining the Quality Assurance programs and Quality Systems at the Hopkinton site. This fully on-site position plays a critical role in ensuring compliance with the company’s Quality Management System (QMS) and applicable regulatory requirements. The individual will collaborate cross-functionally to support manufacturing operations, regulatory activities, and continuous quality improvement initiatives in a regulated medical device environment.
More About Isto
Duties and Responsibilities
Quality Management System (QMS) Compliance
- Ensure compliance with established Quality Management System requirements.
- Support ongoing inspection readiness and quality improvement efforts.
- Maintain quality records in accordance with internal procedures and regulatory standards.
Document Control
- Administer and maintain the Document Control System.
- Ensure proper review, approval, revision, and archival of controlled documents.
- Maintain compliance with QMS documentation requirements.
Regulatory & External Audit Support
- Participate in communications and meetings with representatives from the U.S. Food and Drug Administration, Notified Bodies, and other regulatory authorities.
- Support activities related to Quality System compliance, manufacturing inspections, and Vigilance/Medical Device Reporting (MDR).
- Assist in preparing documentation and responses for regulatory audits and inspections.
Quality Systems Administration
- Maintain the Nonconformance Control and Deviation systems, including documentation, tracking, and closure.
- Support and maintain the Corrective and Preventive Action (CAPA) system, including root cause investigations and effectiveness checks.
- Maintain the Complaint Handling system in accordance with regulatory requirements.
- Oversee and maintain the Training System to ensure accurate tracking of employee training and compliance with procedural requirements.
Auditing
- Conduct internal Quality System audits.
- Support external and supplier audits as required.
- Prepare audit reports and ensure appropriate follow-up on corrective actions.
Manufacturing Quality Support
- Perform manufacturing inspections and in-process quality reviews.
- Conduct manufacturing record review, product approval, and release activities.
- Collaborate with manufacturing teams to ensure compliance with quality standards.
Additional Duties
- Support cross-functional quality initiatives and projects as assigned.
- Perform other duties as directed by the Quality Systems Supervisor.
Required Education and Experience
- Bachelor of Science (B.S.) degree in a science-related field or equivalent experience in an FDA-regulated industry preferred.
- Experience working within a Quality System preferred.
- Experience conducting internal and external audits preferred.
- Knowledge of medical device regulations (U.S., European, and international) and quality assurance principles preferred.
- Strong verbal and written communication skills.
- Computer proficiency required.
- Ability to communicate effectively at multiple levels within an organization.
- Strong organizational skills with the ability to prioritize tasks, establish goals, and maintain accurate records.
Schedule: Full time, in-office
This is a fully on-site role based in Hopkinton, MA. The position requires regular interaction with manufacturing operations, senior management and cross-functional teams to ensure compliance and support quality objectives.
Pay: $68,000-$72,000