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Complaint Handler

US Tech Solutions, Inc.

Mountain View, CA

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JOB DETAILS
SALARY
$24.44–$25 Per Hour
SKILLS
Address Management, Auditing, Biology, Code of Federal Regulations, Communication Skills, Computer Skills, Cross-Functional, Customer Escalations, Customer Relations, Customer Support/Service, Establish Priorities, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Internal Audit, Medical Equipment, Organizational Skills, People Management, Physical Science, Presentation/Verbal Skills, Procedure Development, Process Improvement, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Regulatory Reports, Writing Skills
LOCATION
Mountain View, CA
POSTED
30+ days ago
Duration: 6+ Months

Job Function:
  • The primary function of this position is to coordinate and assist field action team related activities. They are to possess a general understanding of the field action process. They will work closely with field action team to ensure that appropriate processing of customer
  • acknowledgement forms and inquiries related to field actions. Collaboration with business partners, field action team, and management to address customer escalation concerns as it related to field action. They will have strong organization and communications skills to support established customer-focused quality initiatives. The specialist will also be expected to assist the team in record retention based on company and regulatory standards.
 
Essential Job Duties:
  • Processing and reconciling customer returned acknowledgement forms per regulations and internal procedures.
  • Provides guidance to customers for product recall related questions.
  • Help provide updates on effectiveness levels for each field action.
  • Assist in preparing monthly regulatory reports on field action effectiveness status.
  • Assist in providing status updates to cross-functional teams when needed.
  • Assists with providing information to Audit Management on maintaining audit readiness for internal and external audits.
  • Performs assessments, develops action plans, and drives plan to effectively manage recall inbox and address any urgent communication appropriately.
  • Collaborate in development, maintenance, and improve processes and procedures for various processes within the quality management system and where necessary.
 
Preferred Skills and Experience:
  • Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field
  • Minimum 4 plus years’ experience in product quality or regulatory compliance (or combined experience) in the medical device or other regulated industry.
  • Has general understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR – Canada, European, RDC – Brazil)
  • Experience with computer regulations/standards and methodologies
  • Strong organizational, written, and verbal communication skills; plus critical thinking skills and proficient in constructive dialogue
  • Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment
  • Effective in collaborating and partnering with field action team and displaying an appropriate level of assertiveness
  • Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred)
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com
 
US Tech Solutions is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring. 

About the Company

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US Tech Solutions, Inc.

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