About Us:
Magic Science Supply, LLC is a healthcare technology-based consumer products company specializing in the manufacturing of hypochlorous acid (HOCl), an antimicrobial disinfectant that kills 99.9% of germs. We believe that keeping families healthy does not have to mean exposing them to harsh chemicals. Our CleanSmart, SkinSmart, and Magic Molecule brands use simple ingredients and smart science to effectively kill germs that make people sick.
Quality Systems Manager
Position Summary
We are seeking a seasoned and strategic Quality Systems Manager to own the vision,
governance, and continuous evolution of our Quality Management System (QMS) in accordance
with ISO 13485 and ISO 9001 standards. This is a senior leadership role responsible for setting
quality strategy, driving enterprise-wide audit readiness, and ensuring regulatory compliance
across all functions and sites. The ideal candidate is an experienced quality executive with a
proven track record of building high-performing teams, influencing cross-functional and
executive stakeholders, and translating regulatory strategy into operational excellence. This
person is a decisive, solutions-oriented leader who is highly detailed, organized, and quick to act
when quality or compliance risks arise.
Key Responsibilities
Own the strategic direction, governance, and continuous improvement of the Quality
Management System (QMS) in compliance with ISO 13485, ISO 9001, and other
applicable regulatory requirements across all sites and product lines.
Serve as the owner of audit readiness programs, building a culture of perpetual
inspection-readiness through mock audits, gap assessments, risk-based self-inspections,
and robust documentation control frameworks.
Establish enterprise-wide standards for audit trails, records management, and evidence
retrieval, ensuring rapid, accurate responsiveness during internal, external, and
regulatory body audits or inspections.
Lead and represent the organization in high-stakes regulatory inspections, certification
audits, and customer audits, acting as the primary point of contact and executive
presence during these engagements.
Set the strategic direction for CAPA, root cause analysis, and risk management programs,
ensuring systemic issues are resolved at the source and do not recur.
Partner with senior leadership across Production, Engineering, R&D, and Regulatory
Affairs to embed quality strategy into business planning, product development, and
operational decision-making.
Develop and own quality budgets, resourcing plans, and departmental roadmaps,
ensuring the quality function scales effectively with business growth.
Define, monitor, and report enterprise quality metrics and KPIs to executive leadership
and the board, translating data into actionable strategic recommendations.
Build, mentor, and develop a high-performing team of quality managers and
professionals, cultivating future quality leaders within the organization.
Own regulatory submission strategy and readiness, ensuring the organization is
positioned for successful outcomes with regulatory bodies (e.g., FDA, notified bodies).
Champion a proactive, solutions-oriented quality culture across the organization,
balancing rigorous compliance with speed and operational efficiency.
Act as the key executive liaison between Quality and other departments, ensuring
quality is a strategic priority embedded across the business, not a downstream function.
Drive organizational change management related to quality systems, policy updates, and
process transformation initiatives.
Required Qualifications
10–15 years of progressive experience in Quality Assurance, Quality Systems, or
Regulatory Affairs, including significant experience in a senior leadership or management
capacity, preferably within a manufacturing or production environment.
Deep, expertise demonstrated in ISO 13485 and ISO 9001 quality management system
requirements, including hands-on experience leading certification and regulatory audits.
Strong command of regulatory frameworks and compliance strategy relevant to the
industry, with experience interfacing directly with regulatory bodies.
Proven track recording or scaling a QMS within a complex production or manufacturing
environment, ideally across multiple sites or product lines.
Executive-level leadership skills, with a demonstrated ability to build, mentor, and lead
high-performing teams and develop future leaders.
Exceptional problem-solving and decision-making abilities, with a practical, solutions-
oriented approach to complex, high-stakes quality challenges.
Highly detailed and organized, with the ability to oversee complex documentation,
records, and audit trails with precision at an enterprise scale.
Quick to action and decisive under pressure, able to assess risk rapidly and drive timely
resolution without sacrificing quality or compliance.
Strong collaborator and cross-functional partner, able to influence and align senior
stakeholders across production, engineering, regulatory, and executive leadership.
Excellent executive communication skills, both written and verbal, with experience
presenting to senior leadership and boards.
Bachelor's degree in a relevant field (Engineering, Life Sciences, Quality Management, or
related) required; advanced degree preferred, or equivalent extensive professional
experience.
Preferred Qualifications
Extensive experience leading ISO 13485 and/or ISO 9001 certification audits and
regulatory inspections at an enterprise or multi-site level.
Demonstrated success building and scaling audit readiness programs, including mock
audits, self-inspections, and documentation control systems across a growing
organization.
Deep familiarity with CAPA systems, advanced root cause analysis methodologies (e.g., 5
Why, Fishbone/Ishikawa), and risk management frameworks (e.g., FMEA).
Extensive experience in a regulated industry such as medical devices, pharmaceuticals,
or similar, including direct engagement with regulatory bodies (e.g., FDA, notified
bodies).
Advanced certification such as ASQ Certified Quality Manager, Certified Quality Auditor,
Certified Six Sigma Black Belt, or equivalent.
Experience leading quality system transformations, mergers/acquisitions integrations, or
multi-site QMS harmonization.
What We're Looking For
Beyond technical mastery, we're looking for a seasoned quality leader who brings executive
presence, strategic vision, and decisive, solutions-oriented leadership to the organization. You
should be equally comfortable setting long-term quality strategy in the boardroom and rolling
up your sleeves to resolve a critical issue on the production floor. If you're a highly organized,
quick-acting problem-solver who builds strong cross-functional partnerships and drives lasting
change, we'd love to hear from you.
This job description is intended to convey information essential to understanding the scope of
the role and is not an exhaustive list of skills, efforts, duties, or responsibilities.
Job Type: Full-time
Pay: $125,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Application Question(s):
- Will You Now or in the Future Require Sponsorship to Work in the US? We are unable to sponsor at this time.
Work Location: In person
