The Sr. Complaint Handling Unit (CHU) Manager is responsibility for complaint handling and is process owner for complaint analysis, regulatory reporting, and complaint management. This role will be the subject matter expert, work closely with Commercial, Operations, and Design teams, and interact with regulatory agencies and customers to ensure the Complaint Handling Unit follows complaint handling procedures and regulations.

• Responsible for implementing and maintaining the effectiveness of the quality system including personnel development and assessing performance.
• Provides direct and indirect supervision to professional to ensure that complaints are handled in accordance with Quest policies and procedures.
• Communicates with management in the area of complaints handling and issues affecting product performance and anticipates, recognizes, communicates and manages quality issues within the organization and works with appropriate cross-functional areas to recommend actions to resolve issues.
• Manage day-to-day complaint assignment; support management in day-to-day operations in a fast-paced work environment
• Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements.
• Champions and actively participates in development / improvements of complaint handling processes and procedures.
• Responsible for ensuring that customer complaints are reviewed in a timely manner and elevated to the medical events group as necessary to meet reporting regulations.
• Responsible for ensuring that product quality issues are identified as early as possible and remedied through the corrective and preventive action system.
• Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data
• Work effectively with Customer Service and R&D, as well as other internal and external organizations as needed, to coordinate and facilitate improvements in complaint handling processes.
• Works closely with Complaint Investigation, Supplier QA and Operations teams to ensure that exception reports and corrective and preventive actions are conducted as necessary for complaint issues.
• Facilitate meetings and discussions across multiple organizations as required to improve/enhance complaint handling processes.
• Interacts with Senior and Executive level staff to escalate field compliant issues as necessary.
• The incumbent also has a high level of interaction with FDA and global regulatory agencies including routine communication and inspections.
• Partners with other quality professionals and cross-functional teams to address recurring issues identified throughout the organization.
• 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. 

Required Work Experience: 

• A minimum of 8+ 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.
• Certified Quality Engineer

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