Post Market Surveillance Specialist

We're hiring! If you want your contributions to make a real difference, check out
this new career opportunity with us at Draeger where we are led by the guiding
principle "Technology for Life".

We are looking for a Post Market Surveillance Specialist to join our team. This
is a hybrid positon requiring a minimum of three days in the Andover, MA office.

The Post Market Surveillance Specialist will be responsible for evaluating
potential complaints, initiating timely actions in association with investigating or
coordinating the investigation to complaint closure. Ensure applicable, local,
national and international regulatory requirements are met. Support field safety
corrective actions/recalls, as required. Support FDA Inspections (QSIT and/or For
Cause), ISO Notified Body audits, Competent Authority, customer, and internal
audits.

• Evaluate potential complaints and investigate product quality issues and
  adverse events, review data collection to investigation summary, coordinate
  the implementation or recommendation of Corrective/Preventative Action(s),
  when required.
• Coordinate, investigate, and monitor the efforts of assigned investigators/sub
  investigators; including follow up actions to ensure timely and effective
  investigation results, provide direction as needed. May assign complaints as
  needed.
• Work independently and/or cross functionally with various departments (e.g.
  regulatory offices, local subsidiaries, field service personnel and clinical
  engineering personnel), as well as complainant, to collaborate, gather, and
  evaluate details of the technical investigation information in order to
  effectively establish the cause of the quality issue and ensure a clear, concise
  and complete investigation report is prepared.
• Examine complaint data to determine trends that result in corrective action,
  report complaint trends to management, and assist in post market
  compliance activities, including field safety corrective actions/recalls related
  to complaints.
• Investigate, review, and summarize the results of Engineering,
  Manufacturing, Quality, Service or Supplier evaluations and investigations.
  Participate in Cross Functional Team meetings and Process Improvement
  teams.
• Monitor the status and progression of complaints under investigation. Author
  complaint investigations methods and findings. Determine root cause or
  potential root cause. Monitor the Return Goods associated with complaints for
  efficiency and effectiveness. Provide feedback concerning areas of
  deficiency.
• Assist Regulatory Affairs in FDA inspections, ISO audits, internal audits,
  TrackWise training, and/or suggestions/feedback regarding process
  improvements). Provide detailed Database reports and/or complaint status
  information, as required.
• Performs queries to provide complaint data and ad hoc trend analysis on
  reported product problems/complaints to drive continuous improvements
  within the department and organization.
• Performs other duties as needed and assigned.

Education:

• Bachelor's Degree - or the equivalent in experience, and training.

Related Experience:

• A minimum of 5 years of data collection, analysis, trending and reporting experience in a regulated industry. Medical device experience required; prior experience in the medical/clinical area is desired.
• 3+ years of experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and CMDR regulations, standards, and guidance documents preferred

Special Competencies or Certifications:

• Excellent verbal and written communication skills.
• Analytical approach to problem solving
• Well organized and able to multitask effectively, as well as show assertiveness, when interfacing with other personnel during the complaint investigation process.
• Experience with Trackwise or equivalent complaint tracking system software and Microsoft Office and database skills are required.
• Knowledge of FDA/ ISO regulations and Country requirements
• Knowledge of MDR and MDV reporting

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into technology for life.