Quality Analyst II

Shoulder Innovations is a medical device startup that is revolutionizing shoulder replacements. They are seeking a Quality Analyst II responsible for managing the field return process for implants and assisting with various quality-related activities.

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

Skills

• 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
• Bachelor's degree in business management, business administration or scientific discipline
• Previous co-op, internship, and/or working experience
• Previous ERP experience (NetSuite preferred)

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

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