What are the responsibilities and job description for the Senior Complaint Specialist position at Shoulder Innovations?
Shoulder Innovations is a venture-backed medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we’ve developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth.
We’re seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on:
- People First: Authentically human
- One Team: Empowered and aligned.
- Innovation: Bold, creative, and daring.
- Growth Mindset: Always curious.
Ready to make an impact in orthopedics? Let’s grow together!
We are seeking a Senior Complaint Specialist who wants to use their knowledge to help grow our venture capital-backed business. Someone who is Independent, organized, and a strong self-starter would be a perfect fit.
As a Senior Complaint Specialist, some of your job duties will include:
- Initiating the complaint file and determining if the information is a complaint or other feedback
- Following up for additional information, including the return of the device, as necessary
- Performing the reportability determination assessment, domestic only
- Complete Device History Record reviews to support investigation as required
- Completion of response letters to the Complainant to inform them of the outcome of the investigation
- Complete investigations when product is not returned for well characterized and understood events as directed by the Quality Department Head
- Submitting the complaint file for review and closure when all tasks are completed
- Understand process performance metrics and drive for achieving the goals
- Lead further investigation into complaint related trends
- Maintain complaint log
- Lead continuous improvement activities
To be successful as a Senior Complaint Specialist, you will have the following experiences and skills:
- Minimum Bachelor’s degree in biology, life science or similar degree and 2 years of related work experience or an equivalent combination of education and work experience
- Medical Device Reporting
- Strong knowledge on FDA 820.198, 803 and 806
- Detail-orientated with the ability to multi-task
- Exceptional drive, work ethic and initiative
- Energetic and enthusiastic personality who thrives on diversity and challenge in a role
- Must be able to work collaboratively and operate in a fast-paced environment
- Strong working knowledge of MS Office
- Excellent analytical and problem-solving skills
- Excellent written and verbal communication skills
- Solid organizational and time management skills
- Ability to be independently motivated
If you believe that you are a perfect fit to join our team as a Senior Complaint Specialist, please consider applying today. To learn more about what Shoulder Innovations does, please visit us at www.shoulderinnovations.com.
