Quality Control Specialist - Imbed Biosciences, Inc

Are you passionate about building and creating things? Do you crave the satisfaction that comes from knowing that the work that you do every day is important?  Are you an excellent communicator and team member?  Do you exemplify our core values of Humility, Integrity, Hunger, and Accountability?  Ready to make a daily impact on the lives of patients around the world?  If so, then we want you on the Imbed Biosciences team!

Job Summary

In this role, you will oversee the company quality control system. The Quality Control Specialist reports directly to the Director of Quality and is primarily responsible for managing company Quality Control System. This includes product related activities including but not limited to Incoming Material Inspection, In-Process Inspection and Finish Goods Inspection. This position plays a critical role in interfacing with all internal departments and external customers. The Quality Control Specialist focuses on the product 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 Control department and will assist in creating and updating the standard operating procedures ("SOP").

Roles and Responsibilities

• Receiving acceptance activities. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented.
• In-process acceptance activities. Ensure that in-process product is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received, and are documented.
• Final acceptance activities. Maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until all acceptance activities have been complete.

May also be required to:

• Assist in the performance of internal audits and external audits.
• Be responsible for calibration and/or maintenance of Quality Inspection instrumentation.
• Perform Environmental Monitoring and aid in the treatment of waste, its removal, and interactions with regulatory authorities (MMSD, DNR, etc.).
• Conduct reviews and inspections associated with DHR’s, and FGR’s.
• Support and enhance 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. Assists in the tracking and trending of data.
• Maintain data integrity and ensure compliance with company SOPs and specifications as well as cGMP, ICH, FDA, EMA regulations or guidelines.
• Maintain compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.
• Perform 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 or invitro diagnostic company.
• Understanding of ISO13485 and FDA QSR Quality System requirements.
• Demonstrated results and experience in an ISO, cGMP, or other regulated environment.
• Auditor or 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.  

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 want you on the Imbed team!