This position is a full-time exempt position. Quality System Coordinator is a customer facing position tasked with ensuring that BFDf is in compliance with relevant regulations and standards. The Quality Compliance Specialist provides support and helps administer the internal and external audit programs. This position could also be tasked to support other aspects of the Quality Management System. This position regularly interacts and/or collaborates with other departments within BFDf. Additional responsibilities may include, but are not limited to, hosting external auditors and providing evidence of BFDf’s compliance to applicable regulations and standards. Such audits may include interviewing executives and employees and/or communicating with external auditors and regulators. May be tasked to assist with what the organization needs to come into compliance. Primary duties will include, but are not limited to:
- 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
- Monitor and track project’s progress and handle any issues that arise
- Act as the point of contact and communicate project status adequately to all participants
- Report and escalate to management as needed.
- Create and maintain comprehensive project documentation, plan and reports.
- 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.
- Interacts with various company departments, including support functions, Manufacturing, Materials, Engineering, R&D, with general support of said departments.
- Strong interpersonal skills and tactful questioning abilities are essential to success in this position.
- This position requires strong computer skills, ability to compile, analyze, and sort data to identify failure modes.
- Interview, investigation, writing, reporting skills are strongly recommended.
- Must have ability to identify non-compliance with a regulation, or set of regulations.
- Follows standard company practices and procedures or applies recognized national standards to specific BioFire Defense projects with direction.
- Normally receives general instruction on routine work and detailed instructions on new assignments, then works independently.
- May represent the company in external audits with support from other Departments.
Training and Education:
- Bachelor Degree, or will substitute equivalent years of experience.
- 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, Demonstrated database, spreadsheet and word processing skills
- 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.
- Solid organization skills including attention to detail and multitasking skills
- Excellent written and verbal communication skills.
- Project management skills, including monitoring and coordinating multiple activities and ability to meet deadlines;
- Understanding of some basic QC and/or Six Sigma skills, such as Control, Run, and Pareto Charts, Histogram, Scatter Plot, Gantt chart, Fishbone Analysis, Affinity Diagram, or Process Capability;
- Negotiation skills required to act as liaison between R&D, Engineering, Production, and QA and advocate for the Quality System
- 4 Weeks of PTO
- 11 Paid Holidays
- Participation in Company's Wellness Program (discounted medical premiums)
- Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)
- Stimulating work environment
- Convenient location near I-15 and Trax Station
- Employee Referral Bonus
- Free Parking
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. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.