QMS Specialist

The Quality Management System Specialist is responsible for managing post market surveillance activities inclusive of documenting, analyzing, and managing customer feedback, complaints, communications and reporting per applicable regulatory requirements. This will include collaborating and ensuring the technical application of applicable regulatory requirements within customer support, product development and maintenance of software platforms, software and hardware devices and solutions at Biofourmis. 

 Key Areas of Responsibility

Reporting into Q&R, the QMS Specialist will have responsibility for;

• Following and maintaining post market procedures to ensure product feedback is appropriately managed, utilized to improve products and services, and is complaint with regulatory requirements.
• Ensuring consistency and adequacy of complaint receipt, reporting, documentation, and investigation of product complaints.
• Managing, reviewing, and approving product complaint records.
• Supporting technical investigations as necessary, coordinating and collaborating with technical support and product development on trend analysis, and corrective action.
• Supporting and guiding product development and service teams to ensure compliance to applicable requirements and regulations.
• Supporting the Biofourmis Quality System by championing and /or supporting CAPAs, Internal and external Audits, and Supplier Qualifications elements as needed.
• Assisting with risk management activities such as HA, FMEA, and Human Factors, and Cybersecurity as applicable
• Analyzing and supporting root cause analysis and driving continuous improvement
• Supporting the monitoring, measurement, and maintenance of the established Quality Management System processes

Job Overview: 

• Ensures customer feedback is managed to established procedures and meet required policies, regulations, and customer requirements.
• Provides guidance and support on administrative and operational activities related to customer feedback to ensure the effective achievement of business objectives with full quality and regulatory compliance
• Has broad expertise and unique domain knowledge in the areas of product complaints, regulatory reporting requirements, trend analysis, and root cause / corrective action steps required to support the improvement of products and services.
• Has the necessary technical, educational, and work experience to become highly knowledgeable with the organizations products.
• Regularly interacts with cross functional departments leads to collaborate and formulate plans to achieve desired outcomes.
• Works on challenges that require in depth knowledge of quality and regulatory principles and practices.

Minimum Requirements 

• Typically requires a scientific degree within life sciences, data science, computer science, or other relevant technical discipline with 3 years similar experience in regulated industry, 2 years with a Masters, and 1 years with a PhD.
• Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR parts 50 (GCPs), 803, 806, 812, and 820, ISO 13485, 14971, EU MDR, Canadian MDR, and ANVISA.
• 3 years in a regulated environment such as medical device, pharmaceutical, or other relevant fields.
• Experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, Decentralized Clinical Trials, and software development practices such as Agile, a plus
• Knowledge of CAPA, hardware and software based device development, compliance testing, and documentation a plus.

Base salary range for this position is $80,000 to $125,000 based upon experience.