Southlake Medical Devices

Company / Entity: Southlake Medical Devices

Job Location: Southlake, TX 76092, United States (Full-Time In-Person)

Job Title: Device QA Specialist

Reports to: Head of Quality/Chief Quality Officer

Hours: 8:30 AM - 5:00 PM

FLSA Status: Exempt

Employment Type: Full-Time (Full-Time In-Person)

Choice isn’t optional. It’s everything.

In life. In health. In how we fight for our future. But somewhere along the way, medicine forgot that. Today’s system runs on one-size-fits-all answers and a cold “just take this” mentality. It’s efficient. It’s easy. It’s wrong.

Southlake Medical Devices exists to blow that model wide open.

We’re pioneering a new way of doing things, and it starts by handing the decision back to the people who matter... you and your provider. TOGETHER, you choose treatments tailored to your whole self: mind, body, and spirit—including advanced, personalized hormone therapies designed to restore balance and vitality.

We go beyond surface symptoms to uncover the root cause,using today’s breakthroughs to ignite a transition of modern medicine…where insight runs deeper, care is pro-active, and connection is everything. We dig deeper. Treat smarter. And restore something even more powerful than health—your Freedom. This isn’t just healthcare. It’s your comeback story, and that story starts with a choice.

Get Well. Live Well.

Position Overview

Southlake Medical Devices is seeking a detail-oriented and proactive Device Quality Assurance Specialist to join our growing team in Southlake, TX. In this role, you will be the primary steward of our device quality standards, ensuring that every product reaching our practitioners meets the highest benchmarks for safety, efficacy, and regulatory compliance. You will report directly to the Head of Quality/Chief Quality Officer, serving as a critical bridge between our operations, supply chain, and external manufacturing partners.

This is a foundational position ideal for a professional looking to make a measurable impact within a dynamic life sciences organization. You will take ownership of the full device quality lifecycle—from initial receiving inspection and quarantine control to the maturity of our complaint handling and supplier oversight programs. As Southlake Medical Devices continues to expand its medical device portfolio, this role offers a clear trajectory for professional growth and increased responsibility in QMS management.

What Your Day-to-Day Looks Like

Your time will be focused on ensuring operational excellence within our device distribution chain. Approximately 50% of your time will be dedicated to core Quality Assurance and inspection tasks, such as receiving shipments, verifying documentation, and maintaining strict inventory control. Another 30% will involve administrative documentation, managing nonconformance reports, and maintaining traceability records. The remaining 20% is focused on cross-functional collaboration with our supply chain partners, regulatory affairs team, and continuous improvement projects to mature our Quality Management Systems.

Key Responsibilities

• Manage the end-to-end receipt of device shipments, including strict quarantine and release protocols.
• Conduct thorough incoming inspections, verifying product identity, UDI, lot numbers, and packaging integrity.
• Execute dimensional and functional testing using established sampling plans and inspection procedures.
• Maintain precise, auditable records for lot-level traceability and device history.
• Identify, segregate, and document nonconforming product while coordinating effective resolutions with contract manufacturers.
• Support the development and maintenance of device-specific procedures, work instructions, and risk documentation.
• Monitor complaint logs and assist in investigation processes to ensure patient safety and regulatory compliance.
• Collaborate with internal departments to ensure all quality events are tracked and closed in a timely manner.
• Act as a key liaison for supplier performance monitoring and internal audit readiness.

Required Qualifications & Experience

• Bachelor’s degree in a scientific, engineering, quality, or healthcare-related discipline.
• 3+ years of experience in Quality Assurance, Quality Control, or supplier quality within a regulated industry (Medical Device, Pharmaceutical, or Biotech).
• Proficiency in applying product specifications, technical drawings, and inspection criteria.
• Strong understanding of documentation practices, including the ability to maintain GxP-compliant records.
• Experience with FDA regulatory requirements, ISO 13485, or similar Quality Management System standards.
• High level of proficiency with standard business software and the ability to adapt to new electronic quality management systems.

Please note: We kindly ask that candidates only apply if they meet the required qualifications listed above.

Preferred Qualifications (Nice to Have)

• Direct experience in medical device complaint handling and MDR assessment processes.
• Familiarity with sterilization validation records and contract manufacturer oversight.
• Previous participation in regulatory audits or inspections (e.g., FDA, ISO).
• Experience in scaling quality processes in a growing startup or small-to-mid-size organization.

Work Environment & Location Expectations

This is a Full-Time, Exempt, In-Person position based in Southlake, TX 76092. As an onsite role, you will be performing physical inspections and coordinating with local operations daily. A high degree of integrity and focus is required, as the role carries the authority to place products on quality hold to ensure patient safety and organizational compliance. We are looking for an individual who is prepared to be on-site to oversee our physical inventory and maintain our high standards of quality excellence.

We are committed to supporting our team's health,financial future, and work-life balance. Our benefits include:

Healthcare Coverage: Comprehensive health, dental, and vision insurance plans with company-subsidized premiums.

Peace of Mind: 100% company-paid Short-Term Disability (STD), Long-Term Disability (LTD), and Life Insurance.

Retirement Savings: A 401(k) plan featuring a 4% company match to help you build for the future.

Work-Life Balance: Generous Paid Time Off (PTO) so you can relax, recharge, and take care of what matters most.

Our Mission

To empower individuals and providers with personalized,root-cause-focused care that restores health, balance, and freedom.

Our Vision

To lead a transformative shift in modern medicine…where deeper insights, proactive care, and personal choice define the future of wellness.

Our Values

Care: We provide a welcoming, nurturing environment for our staff and our clients.

Growth: We are dedicated to fostering beneficial change for ourselves and those we serve.

Respect: We are unwavering in our commitment to speak with honor and listen without judgement.

Partnership: Working collaboratively to build trust, value diverse perspectives, and achieve shared goals.

Integrity: Acts with honesty,accountability, and alignment to company values