Post Market Surveillance Specialist

COMPANY DESCRIPTION 

At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us! 

POSITION SUMMARY 

The Post Market Surveillance Specialist is responsible for overall Quality Management System compliance with FDA Quality System Requirements, ISO 13485 standard and other applicable requirements. This position implements, maintains, and improves systems to ensure products meet defined quality requirements and customer satisfaction is met, while being a leader to those on their team. 

POSITION QUALIFICATIONS 

Knowledge: Acquired through education, certifications, training, experience.  

• Knowledge of quality standards for medical devices (e.g., ISO 13485, FDA QSR, EU Medical Device Directives and Regulations, Australian TGA, Japanese PMDA, Brazilian ANVISA and Canadian Medical Device Regulations).

Skills & Abilities:  

• Excellent verbal and written communication and analytical skills.
• Excellent organizational skills and attention to detail. 
• Ability to multi-task.
• Sound, systematic problem-solving skills.  
• Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, database management and statistical analysis.
• Effective communication skills, with an ability to work and influence cross-functionally.

Level of Experience:  

• A minimum of 4-6 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485). 
• Clinical experience preferred.
• Experience with complaint handling systems.

Level of Education:  

• A bachelor’s degree or equivalent experience in Engineering, Science, Nursing, related scientific discipline, or equivalent.

Travel:  

Occasional Overnight Travel. Up to 10%.  

ESSENTIAL DUTIES AND RESPONSIBLITIES 

The core tasks, duties, and responsibilities that must be performed on the job.  

• Perform the reportability of customer complaints in compliance with regulations, guidelines, and ensuring on time reporting for the United States, Canada, and the EU (EU MDR), as well as working with regional partners to ensure on-time reporting globally (i.e. Japan, Australia, Europe, Asia, South America, Latin America, and any other regions and regulations where applicable).
  • Lead cross-functional team review of complaints to determine the reportable events. 
  • Manage high risk complaint escalation process.
  • Complete MDR and vigilance evaluations and complete filings as required.
  • Establishing and maintaining a reportability strategy based on input from cross-functional team including Clinical, Post Market Surveillance, and Quality Engineering SMEs as well as leadership.
• Perform tracking and trending of potentially reportable events.
• Establish and maintain good relationships with Global Regulatory Agencies as required with respect to proving on time and accurate reporting according to regional requirements based on established metrics, including but not limited to responding to complaint-related inquiries and requests.
• Ensure Quality System documentation is accurate and comprehensive.
• Establish and update regulatory procedures, work instructions, forms, specifications, and other applicable documentation.
• Lead and participate in activities to determine compliance with applicable regulatory requirements and company standards.
• Establish and maintain strong relationships with manufacturing sites to enforce good investigations and to ensure that adequate corrective actions are being implemented in a timely manner, escalating appropriately for senior management involvement.
• Perform and support other post market surveillance activities such as field safety corrective actions.
• Support internal and external audit activities and facilitate closure of audit findings.
• Manage multiple tasks and deadlines.
• Ability to identify compliance risks and escalate when necessary.
• Demonstrate both creative and critical thinking skills.

OTHER RESPONSIBLITIES 

• Focus on achieving our Company mission.
• Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety. 
• Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
• Use time efficiently; perform job accurately and thoroughly.
• Contribute to building and maintaining a positive team environment.
• Ensure all policies and guidelines are implemented and followed.

QUALITY POLICY 

At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements. 

DEIA STATEMENT 

At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.