Why Us?

With a mantra of Empowering Human Potential, Hanger, Inc. is the world's premier provider of orthotic and prosthetic (O&P) services and products, offering the most advanced O&P solutions, clinically differentiated programs and unsurpassed customer service. Hanger's Patient Care segment is the largest owner and operator of O&P patient care clinics nationwide. Through its Products & Services segment, Hanger distributes branded and private label O&P devices, products and components, and provides rehabilitative solutions to the broader market. With 160 years of clinical excellence and innovation, Hanger's vision is to lead the orthotic and prosthetic markets by providing superior patient care, outcomes, services and value. Collectively, Hanger employees touch thousands of lives each day, helping people achieve new levels of mobility and freedom.

Could This Be For You?

The QA/QC Technician has the responsibilities that will play a vital role in ensuring continued compliance with quality standards and regulations governing the medical device industry. This includes, but is not limited to, 21 CFR 820, Medical Device Directive, ISO 13485, and ISO 14971. The QA/QC Technician will focus primarily on implementing and maintaining the quality system and procedures, assisting in various inspections and audits of product lines, and participating in the continuous improvement of the quality management system. This position requires a high level of attention to detail, strong analytical skills, and the ability to work collaboratively with cross-functional teams.

Your Impact

• Compliance with 21 CFR Part 820: Ensure adherence to the requirements set forth in 21 CFR Part 820, also known as the Quality System Regulation, by interpreting, implementing, and maintaining the necessary quality systems and procedures.
• Quality System Documentation: Assist in the development, review, and revision of quality system documentation, including standard operating procedures (SOPs), work instructions, QC forms, and other relevant documents, to ensure compliance with applicable regulations and industry standards.
• Inspections and Audits: Assist in conducting internal audits, inspections, and assessments to verify compliance with quality standards and regulations. Document findings, report non-conformities, and assist in the implementation of corrective and preventive actions (CAPAs) as required.
• Document Control: Assist in the management and maintenance of the document control system, including the review, approval, distribution, and archiving of controlled documents. Ensure proper document version control and availability of up-to-date documents for relevant stakeholders.
• Training and Education: Assist in the development and delivery of quality-related training programs to ensure that employees understand quality policies, procedures, and regulatory requirements.
• Non-Conformance Management: Support the investigation and resolution of non-conformances by conducting root cause analysis, coordinating with cross-functional teams, and implementing corrective actions to prevent recurrence.
• Data Analysis and Reporting: Collect, analyze, and interpret quality-related data to identify trends, patterns, and areas for improvement. Prepare quality reports, metrics, and performance indicators for management review and decision-making purposes.
• Continuous Improvement: Actively participate in continuous improvement initiatives by suggesting and implementing process enhancements, participating in quality improvement projects, and contributing to the overall effectiveness of the quality management system.
• Supplier Quality Management: Collaborate with various teams to evaluate and assess suppliers, perform supplier audits, and ensure compliance with quality standards and requirements.

Regulatory Compliance Support: Provide assistance during regulatory inspections and audits by maintaining accurate records, retrieving requested documents, and addressing any compliance-related inquiries

Minimum Qualifications

3 years’ working experience in a regulated industry, preferably in the medical device or pharmaceutical sector, with exposure to quality management systems.

High school diploma or GED

Associates or bachelor's degree in STEM or related field is preferred.

Additional Success Factors

• Strong knowledge and understanding of 21 CFR Part 820 requirements and other applicable regulations, such as ISO 13485.
• Familiarity with quality tools and methodologies, such as root cause analysis, statistical process control, and risk management.
• Excellent attention to detail and strong analytical skills to assess and interpret data, identify trends, and make data-driven decisions.
• Effective communication skills, both verbal and written, with the ability to articulate complex quality concepts to diverse audiences.
• Proficient in using quality management software, document control systems, and Microsoft Office applications.
• Strong organizational and time management skills to manage multiple tasks and priorities concurrently.
• Ability to work collaboratively in a team environment and interface with cross-functional stakeholders.
• Quality certifications, such as Certified Quality Technician (CQT) or Certified Quality Auditor (CQA) are a plus.

Our Investment in You

Employees working at least 20 hours per week are eligible for the following benefits:

• Competitive Pay
• Health Insurance
• Dental Insurance
• Vision Insurance
• 8 Paid Holidays per Year
• Paid Vacation Time Off
• Paid Sick Time Off
• 8 hours of paid time to volunteer in your community
• Floating Holiday
• Life Insurance
• Medical Flex Spend Account
• Dependent Care Flex Spend Account
• Free employee assistance program
• 401(k)
• Full-time employees are also eligible for short-term and long-term disability insurance