AIROS™ Medical, Inc. is a medical technology manufacturer, designer, and specification developer specializing in compression therapy. Our team of engineers, quality and regulatory experts, and clinical partners create medical devices that improve quality of life for patients battling lymphatic and venous disorders, including the AIROS 6 and AIROS 8 Sequential Compression Device systems.
At AIROS, we are committed to delivering exceptional products and services to our customers. We are looking for a passionate and detail-oriented Quality Manager to join our team. This role will be based at our corporate headquarters in Audubon, PA. This role will report directly to our Chief Operating Officer.
Overview:
The Quality Manager will be responsible for leading and managing the Quality Assurance (QA) and Quality Control (QC) functions within our manufacturing operations. The Quality Manager will ensure compliance with regulatory standards, implement, and maintain quality systems, and drive continuous improvement to ensure product safety and efficacy.
Key Responsibilities:
Quality System Management:
- Lead the development, implementation, and maintenance of the company’s Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory requirements.
- Ensure compliance with applicable regulatory and industry standards for medical devices, including risk management processes (ISO 14971).
- Manage internal and external audits, including preparing for FDA and ISO inspections and leading the response to findings.
- Maintains training records and ensures that employees are trained on the most up to date materials.
Document Control & Risk Management:
- Oversee document control systems, ensuring all quality documents are maintained and updated as required.
- Conduct risk assessments and other risk management activities to ensure product safety throughout its lifecycle.
Product Testing & Validation:
- Oversee product testing, validation, and verification activities, ensuring compliance with design specifications and regulatory standards.
- Review the Non-Conformance Report (NCR) processes and ensure all NCRs are assigned.
- Reviews testing data to ensure that test data was within an acceptable range.
- Ensures that product is of an acceptable quality before product is released for sale.
- Implement process controls and quality control testing to monitor product quality and process stability.
- Reviews incoming inspection of goods and products performed by Warehouse Manager resolves any issues that may arise.
Regulatory Compliance:
- Ensure products meet all regulatory and compliance standards for quality, safety, and performance.
- Consult with regulatory agencies and notified bodies to maintain product approvals and certifications.
- Oversee the submission of documentation for regulatory purposes, including validation and verification data.
Supplier Quality Management:
- Develop and manage supplier quality programs, including audits and performance reviews, to ensure incoming materials meet product specifications and quality standards.
- Collaborate with suppliers on root cause analysis and corrective actions for any identified non-conformance.
Continuous Improvement:
- Lead continuous improvement initiatives, such as Corrective and Preventive Actions (CAPA), to enhance product quality and manufacturing processes.
- Identify areas of improvement within the production process to reduce defects, improve efficiency, and ensure product reliability.
- Support design control, process validation, and risk management activities.
- Reviews customer complaints and analyzes any trends or patterns and informs the Management team of any trends that have formed that may have an impact on product quality.
Knowledge, Skills & Abilities:
- Strong understanding of quality assurance methodologies, statistical analysis, and process improvement techniques.
- Experience in validation and verification of medical devices.
- Proficiency in quality management software and tools (e.g., QMS, SPC, CAPA software).
- Excellent communication skills to interact with regulatory bodies, suppliers, and internal teams.
- Strong problem-solving abilities and attention to detail.
- Ability to work effectively with cross-functional teams at all levels of the company.
- In-depth knowledge of regulatory requirements including FDA, ISO, and 21 CFR Part 820.
Education and Experience:
- Bachelor’s degree in engineering, Quality Management, Life Sciences, or a related field. Advanced certification (e.g., ASQ Certified Quality Engineer or Certified Quality Auditor) a plus.
- 7+ years of experience in quality management within the medical device industry.
- Technical writing experience preferred.
- Demonstrated experience with CAPA, root cause analysis, and risk management methodologies.
- Experience in Quality Management and ERP Software preferred.
- Experience with engineering and FDA 510(k) submission preferred.
Physical Demands:
- Work Environment: Primarily office-based, with occasional time spent in manufacturing environments.
- Mobility: Ability to sit or stand for extended periods and move within manufacturing and laboratory settings. Occasional climbing on ladders to reach product inventory.
- Lifting/Carrying: Ability to lift up to 50 pounds for handling materials or equipment in the quality testing process.
- Travel: Occasional travel to suppliers, audits, or regulatory inspections may be required.
The above information on this description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as an exhaustive list of all responsibilities, duties and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Why Join AIROS? Great opportunity to join a growing company focused on improving the quality of life for people suffering from chronic conditions. AIROS compensation package includes base salary, medical, dental, and vision coverage, prescription drug plan, employer paid long-term disability and life insurance, and 401(k) with profit sharing eligibility.
Airos is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.
For more information, please check out our website: https://airosmedical.com
