Sr. Complaint Specialist
5900 First Ave S Seattle, Washington 98108 | Direct Hire
Position Title: Sr. Complaint Specialist
Position Description: Protingent Staffing has an exciting direct hire opportunity with our client in Seattle, Washington.
- 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.
- 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.