Position

Status

Department

Position Summary:

This is a full-time, non-exempt position. This individual is responsible for administration and completion of activities related to the Quality Management System (QMS). Primary duties will include:

• Assisting in QMS reviews and process improvements.
• Performing system audits and review to established standards and regulations.
• Maintain records that comply with regulatory requirements, good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).
• Provide support for the CAPA system, including writing and conducting investigations and root cause analyses, outlining corrective plans, and following up on the plans to ensure actions were completed and are effective.
• Provide support for the supplier program which includes attending MRB, taking notes, assisting in supplier qualification and supplier reviews.
• Maintain Quality Management System data and generate system metrics including CAPA timeliness metrics.
• Provide Support to all aspects of the QMS; aid in other QA department duties and projects as assigned.
• Provide back-up, as assigned by manager, to other QA roles and job functions.

This position regularly interacts and/or collaborates with other departments within BioFire in the execution of their duties. It is imperative that this individual has excellent communication skills and can lead inter-departmental meetings.

This position follows standard work practices and procedures, and must operate in accordance with FDA, OSHA, ISO, and applicable government regulations and standards. This individual is expected to work independently or cooperatively with little to no supervision in the completion of assigned tasks.

Training and Education:

• College degree preferred. High School diploma with experience is acceptable.
• Excellent computer skills, including advanced proficiency in MS Word, Excel, and PowerPoint.
• ISO Lead Auditor Training preferred but may be acquired on the job.

 Experience:

• 2 years of formal Quality System experience (e.g., ISO 9000 or GMP/ISO 13485 Quality System) including experience in audit activities preferred.
• 1+ years of medical device laboratory experience, or a degree in scientific, technical writing, or Quality discipline preferred.

Benefits/Compensation:

• We offer competitive salaries
• Vacation/holiday pay
• Medical benefits
• Stimulating work environment