Post Mkt. Surveillance Specialist

The Job Responsibilities

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".

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.

Your Qualifications

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 preferred; 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