Quality Complaint Analyst I

Key AccountabilitiesEssential Functions:

• Ensures that all potentially reportable complaints are reviewed,  escalated and overall managed  in a timely and efficient manner
• Ensures timely and complete review  of complaints  for  potentially  reportable events
• Ensures timely and complete  review of all complaints
• Provides  approval   signoff  for customer complaint  cases where/when  necessary
• Reviews  inquiries for potentially reportable  complaints
• The lead for the product specific RAW process  including creating RAW lines for new failures, reviewing and updating existing  RAW lines and completion of RAW review and sign off.
• Chairing  meeting  and providing guidance  and direction to the Risk Management team
• Responsible for reviewing post Market surveillance reporting
• Trains and develops  subordinates, as appropriate, to achieve   duties and responsibilities
• Ensures that adequate personnel, equipment and material resources are allocated. Supports the hiring process a needed.
• Responsible for routine reviews of all direct reports, including the mid-year and yearly review.
• Escalates relevant information on product complaints to appropriate product management as necessary
• Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints, product family specific validation  testing requirements  and product family specific reliability  development testing
• Lead role in  the product family specific maintenance of an effective  complaint system which is compliant with FDA, ISO and Worldwide standards & regulations
• Follows regulatory requirements for complaint management
• Provides any additional support to Quality Assurance functions on an as needed basis

Secondary Functions:

• May perform, as professional judgment and experience are developed, an expanded range of complex complaint investigations. Assignments may be specific to instrument type.

Budget Managed (if applicable)

• N/A

Internal Networking/Key Relationships

• To be determined based on department needs

Additional Skills & Capabilities:

• Strong skills with Excel required

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent written, verbal and presentation skills
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a team to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision making: Makes decisions based on data and risk determination