Job Description

Quality Complaints Handler

6-month contract

Onsite in Redmond, WA

Key Responsibilities:

• Lead and own end-to-end complaint investigations, ensuring alignment with regulatory and company procedures.
• Retrieve and analyze relevant information from multiple systems to support thorough investigations.
• Collaborate professionally with internal teams and external partners to obtain necessary data.
• Assess collected data for compliance with product specifications and report any abnormalities.
• Maintain accurate, complete, and timely documentation of complaint investigations.
• Update and revise standard operating procedures (SOPs) as needed to reflect current practices.
• Participate in cross-functional quality improvement projects or special assignments as required.

Qualifications:

• Minimum of 2 years of experience in complaint handling or a related Quality role within the medical device industry.
• Familiarity with complaint handling regulations and standards, including 21 CFR 820.198, ISO 13485, and ISO 14971 (preferred).
• Ability to follow well-defined procedures while applying sound judgment and critical thinking.
• Strong attention to detail with the ability to document findings clearly and accurately.
• Experience working with QMS software and navigating cross-functional data sources.
• Excellent communication and collaboration skills.

Education & Training:

• A bachelor’s degree in life science, engineering, or a related field is preferred; equivalent experience may be considered.
• Training in complaint handling, root cause analysis, and quality systems is a plus.

Job Tags

Similar Jobs