PURPOSE AND SCOPE:

The incumbent will provide support and direction to the execution ofthe complaint processes throughout the organization to monitor and analyzeproduct performance data from a variety of internal and external sources.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Ensuresprocesses and systems are effective to receive, review, and investigatecritical product complaints investigation. Reviews for closure various productcomplaints which include reportable complaints. Helps provide customer supportand serves as liaison between Quality Engineering, Postmarket Investigators,and Postmarket Clinical, and sales force regarding potential product problems.

Responsibilities:

Manage postmarket surveillance complaints intake staff

Manageinternational complaints investigations, escalation, and response

Prepareagendas, facilitates cross functional meetings to drive moderate to complexproduct complaint investigations and creates meeting minutes

Workwith Postmarket Surveillance and Quality Engineering personnel to ensurecomplaint records are accurate, complete, and follow good documentationpractices

Performqueries to provide complaint data and analysis on reported productproblems/complaints

Interfacewith distributors, sales force, international representatives, and in-housedepartments for complaint information

Reviewor prepare customer communication (response letters, acknowledgement letters)as appropriate

Drivecontinuous quality improvement

Createor update QMS documents

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

Qualifications

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

BA/BSin a life sciences field and 4 years applicable experience; or 8 yearsexperience working directly with customers in a complaint handling capacity.

EXPERIENCE AND REQUIRED SKILLS:

  • Experience with Class II and Class III medical devices is desired
  • Drug experience a plus
  • Strong attention to detail in composing and proofing-reading materials,establishing priorities, scheduling and meeting deadlines
  • Demonstrated ability to work in a fast-paced environment andsimultaneously manage multiple competing tasks and demands
  • Ability to work independently, take initiative and complete tasks todeadlines
  • Decision-making capability, providing advice to the team
  • Excellent communication skills verbal and written.
  • Strong analytical and data analysis skills
  • Experience leading improvement projects
  • Six Sigma certification a plus


  • * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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