Quality Compliance Specialist

Position Summary

The Quality Compliance Specialist provides Quality Assurance support and helps administer the CAPA program and the internal and external audit programs. The Quality Compliance Specialist will assist with ensuring regulatory compliance for the company, including writing and revising relevant SOPs/WIDs and constructively implementing mechanisms for new regulations, standards, and/or regulatory guidance. They will assist with Quality System Planning and maintaining and collect Quality Management System (QMS) data, including periodic Management Reviews, quarterly reports, and generating system metrics. This position could also be tasked to support other aspects of the Quality Management System to assist with compliance organizational needs.

Other key skills required:

• Candidates will possess independent work habits, strong organizational skills, enhanced attention to detail, and diplomacy.
• This position requires strong computer skills as well as ability to compile, analyze, and sort data to identify trends/failure modes.
• Extensive written and verbal communication skills required including investigation, writing, reporting skills are strongly recommended.
• Ability to scan for new or revised applicable regulatory regulations, standards, and guidelines; review and analyze new requirements, provide periodic updates to select groups.
• Support BFDf quality, design control practices, and risk management activities to ensure regulatory adherence.

Education:

• Degree in scientific, technical writing, or public health is preferred

Experience:

• 3 years of Quality System experience (e.g., ISO 9000 or ISO 13485 Quality System) including experience in audit activities preferred;
• Lead Auditor certification preferred but not required

Benefits:

• Medical
• Dental
• Vision
• 401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing 
• 4 Weeks of PTO
• 9 Paid Holidays
• Paid Winter Break from the work week between December 24 thru December 31 
• 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
• 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.