What are the responsibilities and job description for the Quality Specialist position at Instanosis Inc?
Overview
We are seeking a detail-oriented and experienced Quality Specialist to join our team. The ideal candidate will play a critical role in maintaining and improving our quality management systems, ensuring compliance with industry standards, and supporting continuous improvement initiatives. This position offers an excellent opportunity for professionals passionate about quality assurance, quality control, and manufacturing excellence to contribute to a dynamic organization committed to high standards of product integrity and safety.
Responsibilities
- Support the build-out and maintenance of the Quality Management System (QMS) compliant with FDA QSR (21 CFR 820) and ISO 13485
- Own document control activities, including drafting, revising, routing, and maintaining SOPs, work instructions, and forms
- Coordinate employee training, retraining, and training records
- Support CAPA, nonconformance, deviation, and change control processes
- Assist with risk management activities (ISO 14971)
- Prepare for and support internal audits, supplier audits, and regulatory inspections
- Collaborate closely with R&D, Operations, Manufacturing, and Regulatory teams
- Support complaint handling and post-market quality activities as the company scales
- Help establish quality metrics and continuous improvement practices
- Support root cause analysis and corrective actions based on data collection and analysis to address quality issues.
- Participate in internal and external audits, preparing documentation and facilitating continuous improvement efforts.
- Maintaining documentation related to quality management systems, ensuring adherence to regulatory requirements.
- Collaborate with manufacturing teams to implement process improvements that enhance product quality and compliance.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field
Preferred Qualifications
- Experience in diagnostics or IVD products
- Experience building or scaling a QMS in an early-stage company
- Familiarity with electronic QMS tools (e.g., Greenlight Guru, MasterControl, ETQ)
- Experience supporting FDA inspections or ISO audits
- 2–5 years of Quality experience in diagnostics, medical devices, biotech, or regulated life sciences
- Working knowledge of:
- FDA QSR (21 CFR 820)
- ISO 13485
- Document control and training systems
- CAPA and change management
- Strong documentation, organization, and communication skills
- Comfortable working in a startup environment with evolving processes
- Proven experience conducting quality audits and implementing effective corrective actions.
- Strong understanding of quality assurance (QA/QC) principles
- Ability to work collaboratively within cross-functional teams to uphold high standards of product safety, compliance, and quality improvement initiatives.
Pay: $50,000.00 - $105,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
- Retirement plan
Ability to Commute:
- King of Prussia, PA 19406 (Required)
Work Location: In person
Salary : $50,000 - $105,000