JD: Quality Assurance Specialist

Imbed Biosciences Inc. is currently looking for an On-Site Quality Assurance Specialist. In this role, you will oversee the company quality management system.

Job Summary

The Quality Assurance Specialist reports directly to the Director of Quality and is primarily responsible for managing company Quality Management System. This includes compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility including but not limited to project review for accuracy and compliance, systems implementation and maintenance, documentation management and site-wide systems training.

This position plays a critical role in interfacing with all internal departments and external customers. The Quality Assurance Specialist focuses on the quality of all cGMP operations by assisting with internal audits, customer audits, and inspection readiness.

This role requires highly developed written and verbal interpersonal skills as they will be representing the Quality department and will assist in creating and updating the standard operating procedures ("SOP").

Roles and Responsibilities

• Maintains facility licenses and registrations.
• Organizes documentation and facilitates review in support of client regulatory submissions.
• Executes internal audits, including coordinating the audit with relevant department subject matter experts, performing in-depth assessments of systems and procedures; communicating audit findings to key stakeholders; assisting with the development and review of audit responses.
• Facilitates customer audits, including coordinating audits with the customer and internal stakeholders; hosting audits and providing accurate information regarding the quality systems and operations; overseeing the audit response and follow up actions.
• Supports and enhances effectiveness of the quality system, including reporting metrics; authoring Standard Operating Procedures (SOPs); identifying improvement opportunities; assisting with change control, risk management, and corrective and preventive action processes.
• Maintains data integrity and ensures compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.
• Performs other duties as assigned.

Minimum Qualification and Experience

• Bachelor’s degree in Business, Engineering, or field related to the products being developed required.
• Two to five years of experience in medical device company.
• Understanding of ISO13485 and QSR Quality System requirements.
• Demonstrated results and experience in an ISO, cGMP, or other regulated environment.
• Lead Auditor certification a plus
• Excellent written and verbal communication skills.
• Excellent organizational skills and attention to detail.

WHY YOU SHOULD APPLY: Imbed Biosciences, Inc. is a growing Medical Device company with commercial products being sold in the U.S. and overseas and with many exciting products in the development pipeline.

At Imbed, we understand the mounting pressures on our current and future employees' families because of the COVID-19 pandemic. We offer flexibility, excellent salary and benefits, professional growth and development, and a team that will propel you to succeed!

If you are looking for a place to grow, thrive, innovate, make a difference in patients' lives, and enjoy the work you do, then we w