Quality Analyst II

Shoulder Innovations is a 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. (NYSE: SI). 

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 Quality Analyst II who is responsible for managing the field return process for our sterile implants that are ready to be swapped, as well as reusable instrumentation that has begun to show wear or need upgrading. This role will also assist, as needed, with other Quality-related activities such as incoming receiving inspection, document reviews, and complaint intake.

Responsibilities will include but are not limited to the following:

• Facilitate and/or execute instrument upgrades plans including, coordinating with Distribution / Customer Service as necessary, following up with Distributors on returns, facilitating shipments to SI Suppliers for upgrade processing as applicable, and other related activities.
• Support other inventory exchange activities, inclusive of product recalls, under the direction of Quality Process Manager or Quality Department Head.
• Manage inbound receipt of implants or instruments returned from the field.
• Ensure inventory is properly tracked physically and electronically for swaps.
• Update the product inventory in the ERP system as products are received and added to inventory.
• Ensure stakeholders are informed of the current status of activities.

Additional responsibilities may include but are not limited to:

• Perform the intake process for new complaints, including issuing new complaint numbers and completing intake forms.
• Inspect incoming product and compare packing lists against purchase orders, as necessary to ensure no disruption to distribution/supply chain.
• Complete incoming inspection paperwork and review Device History Records (DHR) files.
• Initiate and issue SCARs to Suppliers in response to non-conformances identified.
• Work with various external customer and internal teams to coordinate expected deliveries, confirm production invoices ready for payment, maintain accurate records and assist in inventory control, and management of DHR files to ensure complete and easily retrievable.

We believe to be successful as a Quality Analyst II, you will have the following:

• Bachelor’s degree in business management, business administration or scientific discipline preferred but High School Diploma or GED acceptable 
• Previous co-op, internship, and/or working experience preferred 
• Previous ERP experience preferred but not essential (NetSuite preferred)
• 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

If you are looking to further your career in a pioneering and evolving industry, apply today for our Quality Analyst II position. We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits. To learn more about us, visit us online at .