Jobs | How To Apply | Main
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
Apply To This Job
Return To List

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

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
Apply To This Job


Fraudulent Job Offer Information

ABIOMED is aware that some job seekers have received false employment offers or recruitment emails from an individual or organization posing as ABIOMED. Individuals or organizations sending these false employment offers may request personal information or funds to further the recruitment process.

Please be aware that ABIOMED will never request passport details, money or other personal or financial information from job seekers. All individuals who are successful in gaining an offer of employment from ABIOMED, whether directly or indirectly, are always required to go through a formal recruitment process including an interview with a member of ABIOMEDís recruitment team.

One quick way to identify scam job offers is to check the email address. Legitimate emails from ABIOMED employees end in Some recent scams have come from email addresses that are similar (i.e.,,, etc.) or email addresses using public domain IDs (<>,<>,<>, etc.). Be aware that sometimes fraudsters even use photographs and names of real people at companies and also create fake websites and marketing materials that look very similar to the companyís genuine website. ABIOMED takes action to shut these false addresses and websites down as soon as we are made aware of them, but often this is only after the scammers have contacted many job seekers.

ABIOMED is taking all necessary steps to investigate this matter further.