Spec, Complaint Handling Unit (CHU) - Sr

The Sr. Complaint Handling Unit Specialist conducts complaint handling activities associated with product complaints including managing end-to-end process of customer complaints, medical device reports (MDRs), maintenance of complaint files, risk management files, and responses to customers.

• Adhere to procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.
• Manage day-to-day complaint assignment; support management in day-to-day operations in a fast-paced work environment
• Assign proper coding of complaints and reportable events
• Evaluates event(s) to determine if it qualifies as a complaint and requires a product investigation.
• Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint for corrective action as needed.
• Generates MDR reports in accordance with Quest procedures and applicable regulations/standards.
• Reviews potential reportable events to determine if regulatory filings are required.
• Perform, monitor, and communicate significant complaint trends, adverse events and other pertinent reports
• Partners with other quality professionals and cross-functional teams to address recurring issues identified throughout the organization.
• Completes product complaint investigations and risk assessment activities with applicable subject matter experts.
• Manages customer relationship and expectations during course of complaint investigation and resolution process.
• Ensures compliance with all federal and international regulations/standards.
• Identify and implement appropriate corrective actions based on complaint analysis to prevent recurrence of issues.
• Monitor the effectiveness of corrective actions and adjust as needed.
• Conduct complaint risk assessment and generate/maintain risk management files.

Required WorkExperience:

• A minimum of 5 years of complaint handling in a GxP environment in the Pharmaceutical, Medical Device or Biotech Industry.
• Strong understanding and application experience of medical device regulations (FDA 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 820, ISO 13485, ISO 15189, CAP, CLIA).
• Excellent analytical and problem-solving skills.
• Strong communication and interpersonal skills to effectively interact with internal and external customers.
• Proficiency in complaint management software and data analysis tools.

Physical and Mental Requirements:

• Capability to move around the lab space and various environments including warehouse, laboratory, office.
• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skits to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Strong communication skills to collaborate with various teams and present finding effectively.

Knowledge:

• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Working knowledge of both FDA 21CFR Part 820 Quality Systems Regulations, ISO13485 standards, and CLIA, CAP, FDA requirements
• Demonstrated knowledge of business impact of compliance issues and risk management.

Skills:

• Strong working relationships with Operations, Procurement, R&D, Regulatory Affairs, and the broader Enterprise Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
• Ability and willingness to roll up sleeves and engage to resolve day-to-day issues.

Education
Bachelor's Degree(Required)

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets