Provide technical expertise in the areas of complaint handling, failure
analysis, and adverse event reporting. Work with Engineers to perform standard
and non-standardized failure investigations of returned products. Document and
analyze complaint data for issues/trends. Train others to perform these duties
Key Duties and Responsibilities:
Specific duties, below, will vary slightly between catheters and lasers.
· Enter complaints into the complaint database within 48 hours of
· Send a complaint acknowledgement of receipt letter to physicians
through the appropriate SPNC Sales Rep. as required.
· Determine if the complaint involves a reportable Adverse Event.
· Communicate with sales reps, Field Service Engineers, Hospital Risk
Management, Physicians, Lab personnel, etc. in order to obtain the information
required in order to complete the complaint form and adverse event reports.
· Prepare adverse event reports and send them to the appropriate
regulatory body (FDA, Competent Authorities) within the required timeframe.
· Copy the appropriate Notified Body at the same time the AE is
· Coordinate with Field Service Engineers to obtain and/or clarify laser
· Complete all required documentation on the complaint form.
· Send an investigation summary report to the Sales Rep in order to
review with the physician as required.
· Update and/or present monthly complaint trend data, as required, for
trend review meetings and QMR.
· Work with the SPNC Receiving Department personnel to obtain returned
· Perform decontamination process for all returned devices.
· Schedule and participate failure investigations with Postmarket and
the Engineering groups.
· Forward the completed investigation form to the designated individual
for completion and closing of the complaint.
· Provide input for product and process improvements based on failure
· Follow current policies and procedures to ensure compliance with all
US and international regulations relating to complaint reporting.
· Participate in both internal and external Quality Audits (FDA, BSI,
· Perform complaint database searches for input to annual reports,
submissions, corrective actions or as requested from Engineering,
· Maintain the MAUDE Database reference book.
· May participate as a member of the safety committee.
· Perform routine cleaning of the decontamination lab, including floor
mopping and wiping down all equipment and work surfaces.
· Maintain supplies of PPE and ensure replacement orders are placed in a
· Supervision Required: Works under general supervision. Work is
subject to frequent review to ensure compliance with objectives and policies
· Supervision Given: Incumbent has no supervisory responsibilities
· Decision Making: Decisions are made within established policies and
Material and Equipment Directly Used:
· Spectranetics Policies and Procedures and Drawings
· FDA, MDD and ISO Medical Device Regulations, including MDR and
Vigilance reporting regulations
· Personal Computers and Microsoft Office software
· Various electrical/mechanical measurement and trouble shooting
· Standard failure analysis lab equipment
· BS/BA degree or Associate degree with four years experience in a
regulated medical device environment preferred as is completed training in
complaint trending/statistical techniques (SPC, Six Sigma, JMP, etc)
· A background as a Healthcare Provider (HCP) is also preferred (EMT,
Medical Tech, etc).
· Experience in medical device complaint handling, adverse event
reporting and device failure analysis is desired.
· Good understanding of Quality concepts and tools.
· Must be proficient in Microsoft Office products
· Knowledge of US and international regulations for medical device
manufactures, including MDR and Vigilance reports is helpful.
The Spectranetics Corporation was founded in the 1980s on excimer laser technology and today markets the only Excimer Laser System approved...