Director of Quality and Regulatory Affairs

Director of Quality & Regulatory Affairs at “Top Workplace”

US Med-Equip LLC is seeking a strategic, tech-forward, and highly collaborative Director of Quality & Regulatory Affairs. Reporting directly to the COO, this pivotal leader will elevate our quality management framework from an internal standard to a market-defining competitive advantage.

Operating as a strategic contributor, you will be the chief architect of our transition from ISO 9001:2015 to ISO 13485 certification, establishing a gold-standard Quality Management System (QMS) optimized for a high-velocity, decentralized medical equipment rental and asset-management model. You will not just audit; you will partner with Regional Operations Directors to embed a culture of compliance, predictive risk mitigation, and safety across our nationwide footprint. Furthermore, you will leverage advanced technology to help our healthcare customers solve their own compliance, recall, and Joint Commission challenges.

A Day in the Life

Strategic QMS & ISO 13485 Establishment

· Build from the Ground Up: Evaluate, select, and spearhead the implementation of a brand-new, enterprise-grade digital QMS platform. Ensure seamless integration with US Med-Equip's proprietary logistics and tracking technologies.

· ISO 13485 Pivot: Design, document, and execute the transition from our current ISO 9001:2015 baseline to full ISO 13485 certification, tailoring clauses (traceability, cleanliness, servicing) to a non-manufacturing distribution/consignment environment.

· Customer-Facing Value: Transform compliance into a commercial advantage by developing tech-driven quality reports and insights that help hospital partners ace their own Joint Commission audits.

Decentralized Branch Operations & Safety

· Virtual Auditing & Tech Adoption: Pioneer remote virtual branch auditing protocols to maintain strict oversight of a vast, decentralized footprint of regional support centers and biomedical support pockets.

· Cross-Functional Influence: Work hand-in-hand with Regional Operations Directors to ensure tactical-level branch managers strictly execute quality, safety, and OSHA SOPs.

· Resiliency & Risk Management: Own the development and continuous improvement of risk-mitigation frameworks, including inclement weather, natural disaster preparation, and business continuity SOPs tailored by region.

Regulatory Compliance & Product Lifecycles

· Medical Device Reporting (MDR): Oversee rigorous medical device reporting processes, ensuring immaculate documentation and swift communication with regulatory bodies and manufacturing partners.

· Predictive Risk Modeling: Introduce advanced risk modeling to vet and evaluate new medical equipment and technologies prior to fleet introduction, safeguarding patient care and capital investment.

· Recall & Inquiry Response: Architect rapid-response workflow for manufacturer product recalls and complex customer quality inquiries, minimizing downtime and maximizing trust.

GOV Regulatory and Quality

· Regulatory:

· Federal Acquisition & Compliance

• Familiarity with FAR (Federal Acquisition Regulation) and DFARS (Defense Federal Acquisition Regulation Supplement)
• Understanding of government contract vehicle structures (GSA Schedule, IDIQs, BPAs, OTA, SBIRs)
• Experience with SAM.gov registration, CAGE codes, and DUNS/UEI management
• Knowledge of Buy American Act and Trade Agreements Act compliance

· Medical Device Regulatory

• FDA 21 CFR Part 820 (Quality System Regulation / QSR) and the newer QMSR alignment with ISO 13485
• FDA 510(k), PMA, and De Novo submission experience relevant to the equipment USME sells or services
• UDI (Unique Device Identification) compliance and GUDID management
• CLIA and Joint Commission standards as they apply to biomedical equipment servicing

· Quality:

· Defense & VA Healthcare

• Familiarity with VA/DoD medical equipment procurement standards and VISN (Veterans Integrated Service Network) requirements
• Experience with DCAA audit readiness (if we pursue DoD contracts)
• Understanding of Section 508 accessibility compliance for any technology components
• Knowledge of cybersecurity frameworks relevant to connected medical devices (NIST SP 800-171, CMMC if DoD-adjacent)

· Service & Maintenance Contracts

• Ability to develop and maintain a quality plan that meets government contract SOW requirements
• Experience writing and executing corrective/preventive action (CAPA) programs that satisfy government auditors
• Calibration and preventive maintenance documentation standards (ISO 17025 awareness)

Additional Responsibilities

· Maintain updated knowledge of equipment, services, and policies through regular professional development training.

· Travel nationally as needed

· All other duties as assigned

About US Med-Equip

Recognized as a Top Workplace, US Med-Equip partners with top hospitals across the nation to provide the highest quality movable medical equipment, beds and therapeutic surfaces. USME, an Inc. 5000 Fastest Growing company, supplies and services equipment rented, maintained, and managed using the latest technology to help healthcare providers focus on their patients’ healing.

Education/Experience

· Experience: 7 years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device, biomedical services, or healthcare logistics space.

· Education: Bachelor’s degree in Engineering, Biomedical Sciences, Healthcare Administration, or a related technical field. Master’s degree or relevant certifications (ASQ CQA/CQE, RAC) a strong plus.

Qualifications

· ISO 13485 Expertise: Proven track record of successfully implementing, auditing, or building an ISO 13485 framework from scratch. Experience adapting manufacturing standards to a service, rental, or asset management environment is highly preferred.

· The "Builder" Mindset: Demonstrated experience evaluating, procuring, and implementing enterprise digital QA/QMS software platforms.

· Influence Without Authority: Exceptional interpersonal skills with a proven ability to lead, coach, and drive accountability across a highly decentralized, nationwide network of operations and biomed peers.

· Tech-Savvy Auditor: Forward-thinking approach to compliance, with experience or strong capability in implementing remote virtual auditing, digital workflows, and data-driven risk modeling.

· Travel: Ability to travel strategically to branches and regional hubs, utilizing robust virtual meeting infrastructure for day-to-day oversight.

· Outstanding listening, communication, collaboration, organization and problem-solving skills

· Highest integrity and relentless commitment to delivering value to customers and co-workers

· Resourcefulness in a fast-paced environment with a readiness to embrace change

· Strong organizational, attention-to-detail, critical thinking and problem-solving skills

· Reports To: Chief Operating Officer (COO)

· Location: Houston, TX (Corporate HQ) / Hybrid with strategic travel

· Position Type: Full-Time

Benefits of Working at US Med-Equip

· Professional development and career growth

· Health, Dental, Vision & Life insurance

· Paid time off starting within the first year

· Employee assistance program

· Flexible spending account

· Health savings account

· Employee referral bonuses

· 401(k)

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Experience:

• QMS & ISO 13485: 4 years (Preferred)
• Regulatory Compliance and Product Lifecycles: 4 years (Preferred)
• Defense and VA Healthcare standards: 1 year (Preferred)

Work Location: In person