Would you like to be part of a team dedicated to continuous improvement and driving value-added changes to product that directly impacts the quality of life for our patients worldwide? Do you enjoy digging into the details to support compliance, regulatory and engineering teams? Do you thrive in a fast paced environment and love paying attention to details?
If your answer is yes, then we may be looking for you!
Spectranetics has an opening for a Postmarket Surveillance Analyst.
What You Will Do: You will provide technical expertise in the areas of complaint handling, failure analysis, and adverse event reporting, while working with engineers to perform standard and non-standardization failure investigations of returned products. Document and analyze complaint data for issues/trends and train others to perform these duties as required.
What You Will Learn: Spectranetics attracts and hires the best talent on the planet! You will be working with a great team of dedicated experts and leaders in the Medical Device Industry who will support your continued growth. You will learn from our Quality Team, Engineering, Manufacturing and many other industry professionals about our state of the art products.
What You Will Become: A highly influential teammate who will be key to ensuring that our internal processes adhere to our high corporate standards to continue to drive us in our mission and values of as we save and improve patient lives by staying on the forefront of safety and innovation. You will have high visibility across the entire organization and learn about every facet in the production of our high-quality, safe and effective, regulatory compliant products and services.
What Success Looks Like:
- Enter complaints into the complaint database in a timely manner, normally the same day received or the next business day
- Send a complaint acknowledgement of receipt letter to physicians through the appropriate SPNC sales representative as required
- Under supervision, determine if the complaint involves a reportable Adverse Event
- Communicate with sales representatives, 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
- Under supervision, prepare adverse event reports and send them to the appropriate regulatory body (FDA, Competent Authorities) within the required timeframe
- Collaborate with field service engineers to obtain and/or clarify laser failure investigations
- Complete all required documentation on the complaint form
- Send an investigation summary report to the sales representative in order to review with the physician as required
- Work with the SPNC receiving department personnel to obtain returned devices
- Perform decontamination process for all returned devices
- Schedule and participate in failure investigations with post-market and the engineering groups
- Forward the completed investigation form to the designated individual for completion and closing of the complaint and follow up as necessary
- Provide input for product and process improvements based on failure investigations
- 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, PMDA or others)
- Perform complaint database searches for input to annual reports, submissions, corrective actions or as requested for engineering. sales/marketing, etc.
- Perform literature reviews including FDA database inquiries
- May participate as a member of the safety committee
- Perform routine cleaning of the decontamination lab, and maintain supplies of PPE and ensure replacement orders are places in a timely manner
- BS/BA degree or Associates degree with four year experience in a regulated medical device environment or equivalent experience preferred
- Catheter Analyst – A background as a Healthcare Provider (HCP) is preferred (EMT< Medical Tech etc.)
- Laser Analyst – A background in electronics or engineering technician is preferred
- Two year experience in medical device complaint handling, adverse event reporting and device failure analysis or four years as HCP
- Good understanding of quality concepts and tools
- Must be proficient in Microsoft Office products
- Knowledge of US and international regulations for medical device manufacturers, including MDR and Vigilance reports
Supervisory Duties: There are no Supervisory duties required of this position. Leadership skills and the ability to positively influence those around you is a critical requirement.
Material and Equipment Directly Used:
- Spectranetics policies, 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 equipment
- Standard failure analysis lab equipment
Agencies that submit a resume to SPNC must have a current executed SPNC Agency Agreement executed by a member of the Talent Acquisitions Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a SPNC Recruiter. All resumes must be submitted to the vendor portal under these terms or they will not be considered.
This job description is intended to describe the general nature and level of work assigned to individual filling this position. This is not intended to be an exhaustive list of all responsibilities, duties or skills required. This job description is subject to change as the needs and requirements of the department and business change.
All applicants must pass a pre-employment drug screen to be hired.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or status as an individual with a disability.