Entry-level position that gives the opportunity to gain hands-on learning experience about regulations within the medical device industry, assist members of the Quality Assurance team by providing organizational and informational support for QMS activities, and gain exposure to the medical device industry. This individual is responsible for administration and completion of activities related to the Quality Management System (QMS). Primary duties will include:
- Supporting the Internal Audit, NCR, and Corrective and Preventive (CAPA) System
- Performing system audits and review to established standards and regulations
- Supporting completion of the internal audit schedule
- Supporting supplier audits as needed
- Maintaining QMS metrics and data related to internal and external audits
- Assisting in QMS reviews and process improvements
- And any other responsibilities as directed by QA Managers and BioFire Defense operating procedures.
This position regularly interacts and/or collaborates with other departments within BioFire in the execution of their duties. It is imperative that the individual has excellent communication skills and is able to 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.
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Defense’s Quality System.
- Maintain records that comply with regulatory requirements, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOP).
- Provide support for the Internal Audit Program, including writing audit reports and conducting audits.
- Provide support for CAPA System, including writing investigations and root cause analyses, outlining corrective plans, and following up on the plans to ensure actions were completed and effective.
- Provide support for the supplier program which includes performing supplier audits.
- Maintain Quality Management System data and generate system metrics including Internal audit timeliness metrics.
- Perform system reviews and audits.
- Use professional concepts to achieve objectives in creative and effective ways
- Maintain and organize quality data in spreadsheets
- 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.
- Interacts with various company departments, including support functions, Manufacturing, Materials, Engineering, R&D, with general support of said departments.
Training and Education:
- 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.
Over 3 years of medical device laboratory experience, or degree in scientific, technical writing, or quality discipline preferred.
- Ability to work effectively with multiple disciplines and personalities.
- Self-starter, with the ability to work and learn independently.
- Ability to collect data and create reports to present to management.
- Ability to analyze data and determine acceptability based on company procedures and training.
- Attention to detail is fundamental to this position.
- Ability to accurately follow written and verbal instructions.
- Excellent written and verbal communication skills.
Our EEO Policy
BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.