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Sr. Supervisor, Global Post-Market Engineering
Job#: 18QA-O2
Positions: 1
Posted: 05/25/2017
Job Type:
Location: Danvers, MA
Department: Quality
Contact: Pam Hinckley
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Job Description

Job Description:

The Senior Supervisor, Post-Market Engineering is responsible for implementing the complaint investigation and reporting systems through the supervision of the complaints team.

 

Principle Duties and Responsibilities:

  • Facilitates the timely completion of complaint investigations
  • Works closely with engineering investigation teams to assure the timely closure of technical investigations
  • Assures proper documentation of complaints and vigilance for notification to the FDA, notified bodies and other regulatory agencies
  • Responds to Request from Regulatory bodies for supplemental information or clarification of existing submittals
  • Generates annual Post-Market Surveillance Reports that are used to update Risk Management Programs and Clinical Evaluations; Identify and implement improvements to the complaint systems and maintain departmental databases
  • Analyzes complaint handling and MDR trending data
  • Prepares complaint handling metrics and trending reports for Sr. Management on a monthly basis
  • Interacts with cross-functional teams to obtain information pertinent to the complaint investigation
  • Assists complaints team in the timely execution of their duties and responsibilities
  • Defines and implements reporting decision trees for new product target markets
  • Implements all decision trees to assure compliance with all regional regulatory requirements
  • Monitors proposed post-market surveillance regulatory changes to evaluate their impact, implement strategies to remain in compliance and communicates proposed actions to the organization
  • Provide direction regarding Corrective and Preventative Actions that relate to the complaint system as well as reportable events
  • Interprets global adverse event reporting requirements and guidelines and implements them into the quality system
  • Supervises a team of professional individual contributors
  • Acts as advisor to the group and stays actively involved with the group to meet schedules and timelines
  • Assist management on departmental projects, as necessary
  • Other duties as specified
Skills/Requirements

Job Qualifications:

  • Bachelor, Engineering Degree required
  • 5 years experience in complaint management and failure investigation; Medical device or pharmaceutical industry experience preferred
  • 3 years of Supervisory experience
  • Knowledge of lean, six sigma, kaizen and continuous improvement initiatives a plus
  • Excellent verbal and written communication skills
  • Strong organizational skills; must be detailed-oriented
  • Ability to execute tasks in a timely manner under general supervision
  • Strong knowledge of Microsoft Office Suite and Adobe Acrobat
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