Quality Assurance Specialist
Company: Imbed Biosciences, Inc
Posted on: January 27, 2023
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
- 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
- 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
- Maintains data integrity and ensures compliance with company
SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations
- Maintains compliance with federal, state, local, and
organizational laws, regulations, guidelines, and policies.
- Performs other duties as assigned. - Minimum Qualification and
- 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
- Demonstrated results and experience in an ISO, cGMP, or other
- 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
Keywords: Imbed Biosciences, Inc, Madison , Quality Assurance Specialist, Other , Middleton, Wisconsin
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