Waters Corporation

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Sr. Post Market Surveillance and Vigilance Specialist

Sr. Post Market Surveillance and Vigilance Specialist

Req. # 
7148
Company Name 
Waters Division
Category 
Quality Assurance
Location 
US-MA-Milford
Type 
Regular Full-Time

More information about this job

Company Description

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,000 employees and is represented in over 100 countries around the world.

 

 

Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.

Overview

Under the leadership of the Manager, Complaint Handling, the Post Market Surveillance and Vigilance Specialist will be responsible for the execution of post market and regulatory assessment activities while ensuring complaint handling tasks are completed as required and compliant to internal standards/procedures and applicable external, industry regulations and standards. The Post Market Surveillance and Vigilance Specialist position provides an exciting opportunity that will allow a successful candidate to develop within the Waters quality organization. This position will work closely with other departments/groups to maintain cGMP compliance within the post market area. He/she will help drive continuous improvement through CAPA, leading project/continuous improvement activities and providing subject matter expertise on Post Market processes.

Responsibilities

  • Manage and document thorough and accurate complaint records in the TrackWise system while ensuring they are processed in a uniform and timely manner
  • Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP)
  • Oversee reportability (MDR/AE) of complaints to FDA and other international regulatory agencies.
  • Work with the Field Service Organization and various Waters manufacturing facilities to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements both domestic and international
  • Lead the Collection, Review, tracking, trending, analysis, and reporting of complaint data generated from the complaint handling system to create monthly and quarterly reports
  • Drive identification of complaint trends and signals that can feed the CAPA process to drive continuous improvement for Waters medical devices and the Complaint Handling Process, as needed.
  • Leads the in the preparation of HHEs (Health Hazard Evaluations)
  • Support post market surveillance reporting activities
  • Lead key project initiatives as necessary
  • Provides guidance and training to support staff and new analysts. May provide supervision/performance feedback of group to Management.
  • Takes lead on specific complaint issues and coordinates with other departments to further investigate.
  • Can act as substitute department representative during internal and external audits.

Qualifications

  • Bachelors degree, preferably in a life sciences or related field of study or equivalent experience
  • Minimum of 5+ years experience with Complaint Handling in the biotechnology, medical device or pharmaceutical industry
  • Understanding of the domestic and international requirements for Complaint Handling, Medical Device Reporting, and Vigilance (QSR, ISO 13485, etc.)
  • Excellent communication skills, both written and verbal.
  • Problem solving skills
  • Able to work well within a team
  • Ability to identify root cause and drive corrective actions
  • Highly organized with strong attention to detail
  • Self motivated
  • Proficient in MS Word, Excel, Visio, and PowerPoint. Proficiency in Trackwise a plus
  • Ability to prioritize the workload and effective time management

Key Words

Complaint, Quality, Quality Assurance, Complaint Handling, Trackwise, Post Market, HHE, HHA, Health Hazard Evaluations, Health Hazard Assessments, CAPA