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.ResponsibilitiesFacilitate 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 activitiesSupport other inventory exchange activities, inclusive of product recalls, under the direction of Quality Process Manager or Quality Department HeadManage inbound receipt of implants or instruments returned from the fieldEnsure inventory is properly tracked physically and electronically for swapsUpdate the product inventory in the ERP system as products are received and added to inventoryEnsure stakeholders are informed of the current status of activitiesPerform the intake process for new complaints, including issuing new complaint numbers and completing intake formsInspect incoming product and compare packing lists against purchase orders, as necessary to ensure no disruption to distribution/supply chainComplete incoming inspection paperwork and review Device History Records (DHR) filesInitiate and issue SCARs to Suppliers in response to non-conformances identifiedWork 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 retrievableSkillsHigh School Diploma or GED acceptableDetail-orientated with the ability to multi-taskExceptional drive, work ethic and initiativeEnergetic and enthusiastic personality who thrives on diversity and challenge in a roleMust be able to work collaboratively and operate in a fast-paced environmentStrong working knowledge of MS OfficeExcellent analytical and problem-solving skillsBachelor's degree in business management, business administration or scientific disciplinePrevious co-op, internship, and/or working experiencePrevious ERP experience (NetSuite preferred)Benefits401(k)401(k) matchingDental insuranceHealth insurancePaid time offVision insuranceCompany OverviewShoulder Innovations is a medical device company that develops inset glenoid fixation technology. It was founded in 2015, and is headquartered in Holland, Michigan, USA, with a workforce of 11-50 employees. Its website is http://shoulderinnovations.com/.



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