Director Of Quality

Factory6 • Lindon, UT

3d • Onsite

About The Position

The Director of Quality leads Factory6’s Quality and Food Safety organization within a regulated nutraceutical manufacturing environment. This role owns Quality Assurance, Quality Control, and the Food Safety program, ensuring Factory6 maintains strong, scalable systems that support product quality, customer confidence, regulatory compliance, and continued business growth. As the executive owner of Factory6’s certification portfolio, the Director of Quality is responsible for maintaining and advancing key certifications, including NSF/ANSI 455-2, SQF with the Costco Addendum, and any additional certifications needed to support customer and market commitments. This leader plays a critical role in preparing for and leading regulatory inspections, customer audits, and third-party certification audits. The ideal candidate will bring both technical depth and practical leadership — someone who can mature quality systems, strengthen audit readiness, improve decision speed, and build a culture of compliance, accountability, data integrity, and continuous improvement across the manufacturing facility. This role operates within the regulatory framework of 21 CFR Part 111, FSMA, and applicable global quality and food safety standards.

Requirements

• Bachelor’s degree in Food Science, Microbiology, Biology, Chemistry, or a related life science / biological science required.
• Minimum 8 years of progressive quality and/or food safety leadership experience in a regulated manufacturing environment, with at least 4 years at a manager or director level.
• Demonstrated experience personally leading and successfully obtaining and maintaining SQF certification, including audit hosting, corrective action ownership, and recertification.
• Hands-on experience with the SQF Costco Addendum and successful Costco supplier audits.
• Proven track record of leading and maintaining NSF/ANSI 455 certification, or an equivalent dietary supplement GMP scheme, without unresolved major findings.
• Direct experience designing and implementing a rapid micro testing program, including platform evaluation, method validation, and operational rollout.
• Strong working knowledge of 21 CFR Part 111, FSMA Preventive Controls, HACCP / HARPC, and supporting regulatory frameworks.
• Experience leading and developing teams across QA, QC, and food safety functions.
• Excellent written and verbal communication skills, with the ability to represent Factory6 confidently in front of regulators, certification bodies, and major customers.
• Sound judgment, ownership mindset, and ability to drive principled decisions under audit and operational pressure.

Nice To Haves

• Master’s degree in Food Science, Microbiology, or related life science.
• Current SQF Practitioner certification.
• PCQI certification.
• Lead Auditor certification, such as SQF, FSSC 22000, or equivalent.
• Experience with additional certification schemes such as organic, kosher, halal, gluten-free, NSF Certified for Sport, FSSC 22000, or BRCGS.
• Experience in dietary supplement contract manufacturing and stickpack, capsule, or bottled formats.
• Lean, Six Sigma, or continuous improvement training with demonstrated application in a quality setting.

Responsibilities

• Lead Factory6’s overall quality, food safety, and compliance strategy across QA, QC, laboratory, and production support functions.
• Ensure compliance with applicable regulatory, certification, and customer requirements, including 21 CFR Part 111, FSMA Preventive Controls, HACCP / HARPC, SQF, the Costco Addendum, and NSF/ANSI 455.
• Maintain effective quality systems for documentation, batch review, product release, deviations, CAPA, complaints, change control, supplier quality, and risk management.
• Provide quality leadership for product hold, release, rework, rejection, escalation, and customer-impacting decisions.
• Promote a culture of quality, food safety, accountability, and continuous improvement throughout the organization.
• Lead preparation, execution, and follow-up for regulatory inspections, third-party certification audits, customer audits, and internal audits.
• Own the maintenance and improvement of Factory6’s certification programs, including SQF, Costco Addendum, NSF/ANSI 455, and future certifications required by customer or business needs.
• Ensure audit findings, corrective actions, and root cause analyses are completed thoroughly, on time, and with appropriate effectiveness verification.
• Serve as Factory6’s primary quality representative in interactions with regulators, certification bodies, customers, suppliers, and other external partners.
• Oversee QC laboratory operations, including raw material, in-process, and finished product testing programs.
• Ensure laboratory methods, instruments, specifications, contract labs, and testing records meet regulatory, certification, and customer expectations.
• Drive improvements in laboratory efficiency, testing reliability, data integrity, and product release cycle time.
• Lead the evaluation, validation, and implementation of a rapid microbiological testing program that improves speed of decision-making while maintaining compliance and data quality.
• Lead, develop, and support the Quality Assurance Manager and broader quality team.
• Establish clear expectations, priorities, KPIs, and development plans for the quality organization.
• Partner closely with Operations, Supply Chain, R&D, Sales, Customer Service, Finance, and other teams to support production, new product introductions, customer onboarding, supplier quality, and issue resolution.
• Use quality data, trends, audits, complaints, deviations, and performance metrics to identify risks, prevent recurrence, and drive continuous improvement.

Benefits

• Office and manufacturing/laboratory environment; significant time on the production floor and in the lab is expected.
• Required to wear appropriate PPE, including safety glasses, hairnet, beard net, hearing protection, and lab coat, when in production and laboratory areas.
• Ability to walk, stand, and move throughout the facility for extended periods.
• Ability to occasionally lift and carry up to 35 pounds.
• Comfortable working in environments with varying temperatures, noise levels, and the presence of dust from raw and packaging materials.
• Periodic travel to suppliers, customers, certification bodies, industry events, and other Factory6 sites as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Director