Sr Manager, Quality Customer Complaints

Job Summary:

The Sr. Manager, Quality Customer Complaints is responsible for management of the complaint handling process, which includes the following: the documentation, investigation, timely processing, closure, monitoring and follow up on of customer complaints.

Duties & Responsibilities:

• Manage the day to day complaint handling process and all related activities:
  
  
  
  • Participating in product analyses and failure investigations, as required;
  • Collaborate with clinical team on review of complaints with regard to patient risk and safety assessments;
  • Provide training and direction to internal team members on the Company's complaint handling process and requirements;
  • Interface with hospital risk management personnel and physicians during the process of conducting investigations for adverse events;
  • Drafts and reviews customer responses;
  • Escalate complaints when new failure modes are encountered or SCARs are issued, and work with OEM, Engineering, Field Personnel, and Quality Assurance to facilitate investigations and generate responses to customers;
  • Actively participate on Quality and cross-functional project teams as needed;
  • Monitor trends in areas of responsibility and escalate issues to management, as needed;
  • Represent complaint management function during internal and external audits;
  • Ensure that all complaints requiring customer responses are properly addressed;
  • Administrative activities related to the management of the complaint handling team;
  • Coordinate and review the work of assigned team members; coordinate work schedules; assist management in developing standards for acceptable levels of performance within the work unit; monitor and report on performance against established standards; report on performance for the purpose of identifying training and development opportunities for staff; provide input on hiring, promotion, demotion and termination decisions; provide input for staff annual performance appraisals and salary increase decisions; provide technical guidance and/or subject matter expertise for staff; may approve hours worked and time off requests;
  • Perform other duties or special projects as assigned
  
  

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• Five years of experience processing complaints in medical device industry;
• Prior management or supervisory experience;
• Prior experience with MedWatch and/or international reporting requirements;
• Experienced in FDA Quality System Regulations- 21 CFR part 820, Part 803 and Part 806 and, Medical Device Directive, EU Medical Device Regulation, and MEDDEV guidance documents, associated harmonized standards, ISO 13485, and related quality standards;
• Skills required:
  
  
  
  • Strong computer skills
  • Strong organizational and analytical skills
  • Ability to interact effectively on a team and with internal and external customers
  • Demonstrated strong leadership and communication skills with attention to detail
  • Ability to multi-task in a fast-paced environment and manage changing priorities
  
  

Preferred Qualifications:

• Clinical experience/background is preferred
• Lean Six Sigma Black or Green Belt certification

Education:

Bachelor's Degree is required, preferably within the Sciences or the Clinical field

Compensation:

The anticipated salary range for this position is $150,000-$180,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

This position also qualifies for up to 20% annual bonus based on Company, department, and individual performance.

Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, Voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center and Cafe. All benefits are subject to eligibility requirements.

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.