Quality Assurance Specialist

At AltimateMedical Holdings, Inc. (AMHI), we improve quality of life for the individuals and clinicians who rely on our products every day. AltimateMedical designs and manufactures differentiated medical equipment across multiple sectors of the healthcare industry. Over the years, we have expanded our portfolio through both innovation and strategic growth, including the addition of respected healthcare brands through MedicalPositioning, ActiveAid, Therafin, and Leggero. As a Granite Partners company, we believe in sharing success and investing in our people. We offer meaningful career growth opportunities, a collaborative and values-driven culture, and the chance to make a direct impact on the lives of those who depend on our products every day.

About the role

We are seeking a detail-oriented and quality-focused Quality Assurance Specialist to support the maintenance and continuous improvement of our Quality Management System (QMS). In this role, you will help ensure compliance with FDA Quality Management System Regulations (QMSR), ISO 13485 requirements, and company quality standards while supporting the delivery of safe, effective, and high-quality products. The QA Specialist plays a key role in product inspection, incoming material verification, calibration management, nonconforming material control, and quality systems support. This position works closely with Operations, Product Development, Procurement, Customer Experience, and other cross-functional teams to drive product quality and regulatory compliance.

Responsibilities

• Product Inspection & Quality Assurance
  • Perform final inspections of finished products to verify conformance to specifications and cleanliness requirements.
  • Document inspection results and maintain accurate quality records.
  • Communicate quality concerns and work collaboratively with production teams to resolve issues before product shipment.
  • Support efforts to improve product quality and customer satisfaction.
• Incoming Inspection
  • Conduct receiving inspections of purchased materials and components.
  • Verify compliance with established specifications and quality requirements.
  • Support product identification, traceability, handling, storage, and distribution controls.
• Calibration Management
  • Manage calibration activities for inspection and test equipment.
  • Schedule and perform verification activities.
  • Coordinate calibration and maintenance activities with internal teams.
  • Investigate and assist in resolving equipment-related discrepancies.
• Nonconforming Material Control
  • Identify, document, and segregate nonconforming materials.
  • Maintain Nonconforming Material Reports (NCMRs).
  • Support supplier quality investigations and corrective actions when required.
• Quality Systems & Continuous Improvement
  • Collect, analyze, and report quality metrics to identify trends and opportunities for improvement.
  • Support the maintenance and enhancement of QMS documentation and records.
  • Assist with Management Review and other quality reporting activities.
  • Participate in quality training programs and support training initiatives across the organization.
  • Contribute to continuous improvement projects that strengthen quality and compliance processes.
• Additional Quality Systems Support

  Depending on business needs, the QA Specialist may also assist with:

  • Customer complaint investigations and follow-up activities.
  • Corrective and Preventive Action (CAPA) processes.
  • Internal audits and audit preparation activities.
  • Supplier quality and corrective action initiatives.

Requirements

• High school diploma or equivalent.
• 2+ years of experience in a manufacturing environment.
• Experience working within an ISO-certified Quality Management System.
• Knowledge of FDA regulations and ISO 13485 requirements.
• Experience with product inspection, calibration programs, CAPA processes, complaint handling, or internal audits.
• Ability to read technical drawings and use measuring and inspection equipment.
• Strong attention to detail and commitment to quality.
• Ability to follow established procedures and work independently.
• Effective written and verbal communication skills.
• Proficiency with Microsoft Office and standard computer applications.
• Strong problem-solving and troubleshooting abilities.

Physical Requirements

• Ability to lift up to 25 pounds.
• Ability to bend, kneel, twist, push, and pull as required during inspection activities.
• Ability to work in manufacturing, inspection, and warehouse environments with varying temperatures and noise levels.
• Ability to wear required personal protective equipment (PPE).

Pay

We offer a competitive hourly rate of $24-$28.80 depending on experience, skills, and qualifications. This position is a non-exempt role, with overtime paid for hours worked over 40 in a workweek (where applicable).

Benefits

AMHI offers competitive pay, annual bonus and profit-sharing opportunities, and market-leading benefits designed to support your wellbeing both at work and beyond. Full-time employees are eligible for a comprehensive benefits package that includes:

• Medical, dental, vision, and life insurance.
• Short- and long-term disability coverage.
• A Health Savings Account (HSA) with company contributions.
• A Vanguard 401(k) with employer contributions.
• Generous paid time off, including volunteer time off and paid holidays.
• Access to the Granite Assistance Fund for support when it's needed most.

Part-time employees may be eligible for select benefits based on scheduled hours and plan requirements.