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Sr. Complaint Specialist

Seattle, Washington 98108 | Direct Hire

Post Date: 03/02/2018 Job ID: 18147 Industry: Project Management

Position Title:  Sr. Complaint Specialist

Position Description:   Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington.

Job Requirements:
  • On a daily basis, reviews and processes assigned complaint records related to product quality and patient safety.
  • Reviews complaints for possible Adverse Events/MDRs and makes regulatory reporting decisions.  Prepares and submits Adverse Events/MDRs to regulatory agencies in a timely manner to meet regulatory deadlines.
  • Conducts and coordinates complaint investigations and the input of information documenting same into the complaint tracking system.
  • Review technical service calls to determine appropriate classification.
  • Work with Factory Service/Engineering to coordinate failure analysis on customer returned product.
  • Ensures complaint files are investigated,  complete and closed in a timely manner.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Assists with gathering, compiling and analyzing complaint trend data.  Participates in complaint review board meetings.
  • Perform other quality assurance and quality control functions as necessary, with appropriate training.

Job Qualifications:
  • Bachelor' s degree (B.S.) from a four-year college or university in the sciences or related field, or equivalent combination of education and experience  
  • Minimum of  6 years’ experience in the medical device industry (or related industry) with complaint handling experience or 6 years of Clinical experience in the medical device industry. 
  • Current knowledge of FDA and international quality system requirements are a must 
  • Specific experience following Device Design Controls and Risk Management Processes  preferred   
  • Experience with Electronic Medical Equipment preferred
  • Technical writing is a plus

Preferred Job Qualifications:
  • Generating  quality metrics
  • The Food and Drug Administration’ s Quality System Regulations (FDA’ s QSR)
  • International standards such as ISO 13485, ISO 14971
  • Medical Devices Directive (MDD)
  • Canadian Medical Device Regulations (CMDR)
  • Product Performance Standards (IEC 60601-1 and collaterals)
  • Project planning a plus
  • Microsoft Excel and Word
  • Must possess strong oral and written communication and interpersonal skills
  • Must possess strong organizational skills
  • Must be adept at handling multiple assignments, multi-tasking, prioritizing and meeting deadlines.
  • Must be able to maintain regular attendance.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Samantha DeLaFuente

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