Quality Analyst II

Shoulder Innovations•Grand Rapids, MI

About The Position

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.

Requirements

Bachelor’s degree in business management, business administration or scientific discipline preferred but High School Diploma or GED acceptable
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

Nice To Haves

Previous co-op, internship, and/or working experience preferred
Previous ERP experience preferred but not essential (NetSuite preferred)

Responsibilities

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.
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.