OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Quality Systems Complaints Specialist. The Quality Systems Complaints Specialist determines the legitimacy of complaint feedback and processes complaint files. This role works with cross-functional teams to communicate with customers and coordinate complaint product return. This role also reviews complaint device history records, supports complaint investigation, and contributes to the ongoing improvement of the quality system.

You will:

Perform initial assessment of customer feedback to determine if the information represents a complaint.
Support the investigation of returned complaint product and complaints where product was not returned.
Perform reviews of the complaint device history records.
Collaborate with Customer Service, Engineering and Operations teams to process complaints in a compliant and timely manner.
Communicate with customers as applicable, including issuance of closeout letters.
Develop and maintain product knowledge of existing and new products. Identify, propose, and drive opportunities for improvement, including review and revision of procedures and associated documents.

You need:

At least 1 year of experience in medical device quality or operations environment
Strong proficiency using MS Office Suite (e.g., Word, Excel, Outlook)
Familiarity with medical device regulations ISO 13485, 21CFR820 and complaints
Strong verbal and written communication skills are essential
Experience with problem solving and root cause analysis
Strong interpersonal skills including negotiating and relationship management
Keen attention to detail and strong organizational skills
Experience using an electronic quality management system (e.g. - QCBD, EtQ, etc.) and an electronic document management system/PLM (e.g. - Oracle's Agile, Documentum, etc.)

NOTE: We are unable to provide any type of sponsorship at this time.

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