Quality Complaints Specialist — Medical Devices (Onsite)

OrthAlign, Inc.; Irvine (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

OrthAlign, Inc. is seeking a Quality Systems Complaints Specialist to assess, investigate, and process medical device complaints in an onsite role in Irvine, CA.

You will work with Customer Service, Engineering and Operations to ensure timely, compliant handling, review complaint device history records, and drive continuous improvement of quality systems while communicating with customers and issuing closeout letters where appropriate.

Qualifications

• At least 1 year of experience in medical device quality or operations environment.
• Strong proficiency using MS Office Suite (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.)

Responsibilities

• 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.

Skills

MS Office

Communication

Problem solving

Interpersonal skills

Attention to detail

Complaints handling

Tools

QCBD

EtQ

Oracle Agile

Documentum

Job description

OrthAlign, Inc. is seeking a Quality Systems Complaints Specialist to assess, investigate, and process medical device complaints in an onsite role in Irvine, CA.

You will work with Customer Service, Engineering and Operations to ensure timely, compliant handling, review complaint device history records, and drive continuous improvement of quality systems while communicating with customers and issuing closeout letters where appropriate.