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Qualitiy System Analyst

Company Name: Midmark Corporation
Location: Torrance, CA
Job Type: Full-Time
Contact Name: Sandra Dancy
Phone: 
Fax: 
Email: apply directly online (see below)
Salary: 65,000 - 70,000

Job Description

Responsible for reviewing services records for complaint evaluation as required by applicable regulations, standards, and company policy. Responsible for processing Corrective and Preventive Action Investigations as assigned. 

ESSENTIAL/PRIMARY DUTIES:

  • Continually gain product knowledge to support relevant Quality System needs.
  • Interfaces with Technical Services and Customer Service to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation.
  • Responsible for receiving, reviewing and evaluating Technical Services intake data into the Post Market Surveillance Process using good documentation practices.
  • Applies knowledge of device regulatory requirements to support the Post Market Surveillance MDR reporting process and evaluates complaints for MDR reporting utilizing product knowledge and Decision Trees.
  • Performs queries to provide complaint data and ad trend analysis on reported product problems/complaints.
  • Interfaces with Quality Engineering and the RGA manufacturing sites as required for product investigations and trending.
  • Investigate, monitor and document CAPA events to ensure thorough and timely corrective action implementation as assigned 

SECONDARY DUTIES:

  • Assists in ensuring timely investigation closure of all complaint files and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.

Process basic submissions of MDR decision trees 

Job Requirements

EDUCATION and/or EXPERIENCE:

Bachelor’s Degree in Engineering or 2-5 years of experience in the field. 

COMPETENCY/SKILL REQUIREMENTS:

  • This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198, 820.100 and 21 CFR 211). Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. This role also partners with Engineering on product investigations and trending

APPLY ONLINE: 

https://midmark.referrals.selectminds.com/jobs/quality-system-analyst-714