Quality Assurance Compliance Manager Full Time NEW

POSITION OVERVIEW

The Quality Assurance & Compliance Manager is a critical leadership role responsible for championing, implementing, and continuously improving the internal compliance and quality framework of our surgical disposable’s resale operation. This individual will serve as the company’s subject matter expert on regulatory requirements governing the acquisition, storage, inspection, and redistribution of overstock, surplus, and facility-closure medical disposables.

While policy development is a collaborative effort — carried out in partnership with executive leadership and department directors — this role owns the implementation, upkeep, and consistent enforcement of all policies once established. The ideal candidate is a proactive, detail-oriented professional who thrives on process ownership, monitors the regulatory landscape for emerging requirements, and ensures that policies remain current, practical, and fully embedded in day-to-day operations.

KEY RESPONSIBILITIES

Policy Implementation & Oversight

• Collaborate with executive leadership and department directors to develop, document, and finalize internal quality and compliance policies and standard operating procedures (SOPs).
• Serve as the primary driver of policy implementation — ensuring that approved policies are clearly communicated, operationalized, and consistently followed across all departments.
• Conduct regular reviews of existing policies to identify gaps, redundancies, or outdated practices; bring findings and recommended updates to leadership for collaborative revision.
• Ensure all SOPs reflect current regulatory requirements and best industry practices; flag needed changes to the appropriate stakeholders promptly.
• Drive consistent, company-wide adherence to all established policies and procedures and hold departments accountable to compliance standards.

Regulatory Compliance & Monitoring

• Monitor federal, state, and local regulations affecting the resale of medical disposables, including FDA guidance, state health department rules, and applicable distributor licensing requirements.
• Track evolving industry standards (e.g., DSCSA traceability requirements, MDR reporting, state licensure renewals) and proactively update internal practices accordingly.
• Maintain up-to-date knowledge of restrictions on the resale of expired, near-expiry, and recalled products.
• Serve as the primary point of contact for regulatory inquiries and agency communications.
• Collaborate with the companies’ legal resources to review policies and assure compliance when legal review is appropriate.

Inventory Quality & Product Integrity

• Review and audit inspection protocols for all incoming inventory sourced from overstock, surplus, and facility-closure channels.
• Audit criteria for product acceptance, quarantine, and disposition of non-conforming goods.
• Audit policy enforcement pertaining to proper handling, labeling, storage conditions, and chain-of-custody documentation for all products.
• Assure policy pertaining to lot/batch tracking and maintain accurate records to support traceability and recall readiness.

Internal Auditing & Continuous Improvement

• Design and execute a regular internal audit schedule covering all operational areas: receiving, storage, order fulfillment, documentation, and sales practices.
• Document audit findings, issue corrective action reports (CARs), and track remediation to closure.
• Benchmark company practices against industry best practices and peer standards; recommend and implement improvements.
• Analyze quality incidents, customer complaints, and near-misses to identify root causes and prevent recurrence.

Training & Culture

• Develop and deliver compliance training programs for all staff, including onboarding and refresher training.
• Foster a company culture where quality and compliance are viewed as shared responsibilities, not obstacles.
• Serve as an accessible resource for staff with compliance questions or concerns.
• Be an active participant and leader in Surgishop’s Governance, Risk, and Compliance committee.

Vendor & Supplier Compliance

• Evaluate sourcing partners for compliance with applicable regulations and company standards.
• Maintain supplier qualification records and conduct periodic reassessments.
• Collaborate in Identifying and escalating sourcing risks related to product authenticity, chain of custody, or regulatory status.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in a relevant field (Healthcare Administration, Life Sciences, Business, Supply Chain, or related discipline); equivalent experience considered.
• 2+ years of experience in quality assurance, compliance, or regulatory affairs within medical devices, medical supplies, healthcare distribution, or a closely related regulated industry.
• Working knowledge of FDA regulations applicable to medical device distribution; familiarity with FDA traceability requirements is a plus.
• Experience developing, writing, and implementing SOPs and quality management documentation.
• Demonstrated ability to conduct internal audits and manage corrective action processes.
• Strong written and verbal communication skills; ability to translate regulatory language into practical workplace guidance.
• High level of integrity, attention to detail, and organizational discipline.

PREFERRED QUALIFICATIONS

• Experience in secondary market medical device or disposables resale.
• Familiarity with state medical device distributor licensing requirements across multiple jurisdictions.
• Relevant certifications such as RAC (Regulatory Affairs Certification), CQA (Certified Quality Auditor), or similar.
• Experience with inventory/ERP systems and quality management software.
• Prior exposure to facility-closure or surplus asset acquisition and disposition processes.

CORE COMPETENCIES

✓ Regulatory Vigilance

Stays ahead of rule changes; anticipates impact on operations.

✓ Policy Development

Writes clear, enforceable policies and holds the organization accountable.

✓ Process Improvement Mindset

Continually looks for smarter, leaner, and more compliant ways to operate.

✓ Collaborative Communicator

Builds trust with staff and leadership; makes compliance approachable.

✓ Analytical & Detail-Oriented

Spots issues in data, documentation, and processes before they escalate.

✓ Integrity & Accountability

Models ethical behavior; prioritizes patient safety and legal compliance above all.

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS

• Onsite Location
• Primary work environment is a warehouse/office setting with exposure to medical supply storage areas.
• Occasional lifting of product samples or documentation materials (up to 30 lbs).
• Regular use of computer systems, ERP/inventory platforms, and standard office software.
• Periodic travel may be required for supplier visits, audits, or regulatory meetings.

COMPENSATION & BENEFITS

• $50 – 65,000 Annually
• Medical Dental & Vision
• Matching 401(k)

Equal Opportunity Employer

We are an equal opportunity employer and consider all qualified applicants without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other legally protected characteristic.