Manager, Complaints and Post-Market

The Manager, Complaints and Post-Market at Noah Medical is responsible for overseeing the complaint handling process, ensuring compliance with regulatory standards. Key activities include managing the day-to-day operations of the complaint handling team, coordinating with various departments to gather necessary information for post-market surveillance, and reviewing complaint files for completeness and accuracy. Additionally, the manager is involved in adverse event reporting and analytics to identify trends and share insights, ensuring the highest quality of our products and customer satisfaction.

To qualify for the Manager, Complaints and Post-Market position at Noah Medical, candidates should hold a minimum of a BS degree in a technical field such as engineering, computer science, or a related science discipline. Additionally, a minimum of 5 years of complaint handling experience in the medical device industry is required. Familiarity with US FDA regulations surrounding complaint processes and a working knowledge of statistical analysis related to complaints is essential.

Success for the Manager, Complaints and Post-Market at Noah Medical is defined by the manager's ability to lead the complaint handling team efficiently, ensuring that all customer complaints are addressed in an accurate and timely manner. Additionally, monitoring complaint metrics and identifying trends that can drive product or process improvements is key. Ensuring compliance with regulatory standards and maintaining the organization’s commitment to quality will also be critical indicators of success in this role.

Noah Medical offers a comprehensive benefits package to the Manager, Complaints and Post-Market, including a competitive salary, health insurance plans (medical, dental, and vision), and an equity and bonus program. You'll also enjoy 12+ paid holidays, generous PTO, parental leave, and various wellness programs, including mental health support. Further opportunities for professional growth are provided through on-demand training and reimbursement for educational materials.

The work culture at Noah Medical is collaborative and supportive, with a shared mission of revolutionizing medical technology. As a Manager, Complaints and Post-Market, you will be part of a detail-oriented team that values quality and cherishes individual contributions. The emphasis on continuous learning and team-building events fosters an engaging environment where innovation thrives, and every team member is encouraged to make a positive impact.

In answering this question, it's important to highlight specific examples from your past roles where you managed complaints, detailing the processes you followed, the challenges you faced, and how you ensured compliance with regulatory requirements. Mention any methodologies you used for complaint investigation and tracking metrics to improve the quality of results.

Emphasize your approach to organization and time management. Explain how you assess the urgency of complaints and allocate resources effectively. Mention specific strategies you utilize to ensure your team's workflow remains efficient and that all complaints are addressed in a timely manner.

Detail your understanding of FDA regulations related to complaint handling, such as 21 CFR Part 820. Discuss how you stay updated on regulatory changes and how you implement those changes within your team. Provide an example of how you successfully ensured compliance in a previous role.

Discuss your philosophy on leadership and mentorship. Highlight specific training initiatives you've implemented to elevate your team's performance and understanding of complaint handling processes. Provide examples of how you've motivated your team through professional development opportunities.

Use the STAR method - Situation, Task, Action, Result - to illustrate a specific complaint scenario. Describe the details of the complaint, the steps you took to investigate, manage, and resolve the issue, and the positive outcome that led to improved processes or customer satisfaction.

Mention any relevant tools or software you've used to track complaints and gather analytics, such as databases or quality management systems. Discuss the metrics you find most valuable in assessing complaint trends, and how data-driven insights help influence decision-making within your team.

Explain your approach to preparing for audits, highlighting your attention to detail and meticulous record-keeping. Discuss how you ensure your team is well-prepared for both internal and external audits and any experiences you've had leading successful audits with positive results.

Share the importance of collaboration with other departments such as clinical, marketing, and R&D. Discuss how you push for a proactive approach to data gathering and analysis to enhance post-market surveillance activities and ensure continual product improvement.

Articulate the essential skills and qualities such as strong analytical skills, excellent communication abilities, attention to detail, and the ability to lead a team effectively. Emphasize the importance of building relationships with cross-functional teams in facilitating successful complaint resolution.

Discuss your commitment to professional development — whether through industry conferences, publications, regulatory body updates, or networking. Share how you integrate this knowledge into your team's training and operational practices to maintain compliance.