The Senior Post Market Engineering Supervisor 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.
Prepare 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.
Implementing 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.
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