Product Complaints Specialist

About Aspen
We love what we do! At Aspen Surgical we live our values of Customer Focus, Integrity, Accountability, Collaboration, and Innovative Spirit every day. This caring dedication creates and builds exceptional products that drive the industry standard making a real and lasting impact on people’s lives around the world. We strive to be the best, while providing the tools, resources, and support needed to set our team members up for success.

Summary
The purpose of this role is to manage the customer complaint processes. This includes customer communication and liaison, event logging, basic investigations, action management/tracking, documentation reviews, RMA coordination, customer restitution, closure activities and metric management.

In This Position, You Will Have the Opportunity To
The Product Complaint Specialist is a key role in performing tactical actions, managing and overseeing the execution of activities within the complaint process along with serving as the liaison with the customer and account management.

Intake:

• Ensure thorough understanding of all received customer feedback that is assessed to be an alleged product defect (i.e. a complaint).
• Log, update, and maintain accurate records of complaints and related resolutions.
• Coordinate activities for the return of goods to be evaluated when applicable.

Investigative Support:

• Support and lead routine complaint management site meetings to ensure investigation progress and containment activities are performed adequately and in a timely manner.

Closure / Conclusions:

• Collaborate with sites to determine required customer restitution and ensure that customers receive remedies and appropriate responses. Additional communication and coordination with account management may also be required.
• Review final details for adequacy and compliance prior to closure. Address any gaps as required.

Monitoring / Oversight:

• Participate in internal, customer, regulatory, and/or Notified Body audits as required
• Write, train and ensure proper documentation, implementation and enforcement of the complaint management process and system utilization.
• Manage the preparation of complaint metrics and reports including the creation, update and maintenance of trend reporting as required
• Initiate and support escalations of complaint issues and identify trends as necessary that support continuous improvement.
• Participate in complaint reportability assessments and ongoing process oversight.
• Support Post Market Surveillance (PMS) assessments and Risk Management activities such as FMEA’s.

What You Need to Succeed in This Position

• Bachelor’s degree in Business and/or related Technical field preferred plus 1-3 years of experience or equivalent combination of education and experience.
• Customer Complaint Management experience within a Medical Device or similar related industry preferred.
• Technical aptitude required, with the ability to understand basic mechanics and manufacturing processes.
• Basic understanding of root cause problem solving analysis and effective correction actions.
• Excellent written and verbal communication skills, with the ability to communicate information clearly to both customers and internal teams.
• Ability to collaborate effectively with various departments, including Regulatory, Quality, Operations, Customer Service, Sales and Marketing.
• Flexibility and Adaptability: Ability to make informed decisions and maintain effectiveness in dynamic environments, adjusting to shifting priorities while balancing results, metrics, and customer satisfaction.
• Experience in leading meetings and motivating team members
• High level of accuracy and attention to detail in documenting complaints and following up on resolution processes.
• Proficient in Microsoft Office including Word, Excel, PowerPoint and Outlook

Quality and Regulatory Requirements

• Basic knowledge of quality systems including procedures, documentation, records, complaints, CAPA, SCAR’s

PHYSICAL REQUIREMENTS:
NOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function, and the applicant is unable to perform such function with or without reasonable accommodation

• Ability to sit or stand for extended periods of time and work with computers or other office equipment.
• Occasional travel may be required

We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Diversity makes us better.