JOB DESCRIPTION:
SUMMARY OF POSITION:
The candidate will support the Post Market Vigilance Investigations team s activities for the Surgical Solutions Division.
These activities include
• assist in managing the receipt of incoming physical complaint product,
• conducting follow ups with accounts and/or International Subsidiaries to rectify discrepancies with product receipt,
• assisting in managing the process flow of complaint investigations,
• performing Device History Record Reviews,
• and performing root cause analysis on General Surgical Product customer returns to ensure high levels of quality, reliability, safety, and efficacy.
Additional responsibilities include
management of clinically applied medical device retains and associated paper records in accordance with Client Record Retention Policies and support staffing needs.
ESSENTIAL FUNCTIONS:
• Assist PMV Investigations Coordinator with managing receipt of physical complaint product samples, in addition to corresponding with domestic and international accounts to rectify discrepancies in product receipt.
• Assist in the prioritization of complaint investigations.
• Assist in the coordination of sanitization of clinically applied medical device returns and shipment to respective Client Manufacturing facilities, as well as coordinating the investigation process with internal
• Engineering and Quality groups.
• Test and thoroughly evaluate rudimentary surgical products to determine root cause analysis within a closely monitored time frame.
• Certification with OSHA s BloodBorne Pathogens Standard 29 CFR 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies.
MINIMUM REQUIREMENTS:
Education Required: High School Diploma
Education Preferred: BS Degree in a Technical curriculum preferred or equivalent industry experience.
Minimum Experience:
• Experience in a laboratory environment and with laboratory equipment or
• academic knowledge in scientific research methods.
• Experience with medical devices preferred but not required.
Skills/Qualifications:
• Must be proficient with MS Office (with emphasis on Excel and Word).
• Time management skills.
• Critical independent thinking and timely follow up.
• Excellent written and verbal skills necessary.
• QD003425-001, Rev A
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
• Quality Assurance
• Manufacturing
• Engineering
• Research and Development
• Regulatory Affairs
• Legal
• Marketing/Sales
WORKING CONDITIONS:
Bio hazardous laboratory environment requiring use of personal protective equipment in accordance with CDC and OSHA regulations.
SUMMARY OF POSITION:
The candidate will support the Post Market Vigilance Investigations team s activities for the Surgical Solutions Division.
These activities include
• assist in managing the receipt of incoming physical complaint product,
• conducting follow ups with accounts and/or International Subsidiaries to rectify discrepancies with product receipt,
• assisting in managing the process flow of complaint investigations,
• performing Device History Record Reviews,
• and performing root cause analysis on General Surgical Product customer returns to ensure high levels of quality, reliability, safety, and efficacy.
Additional responsibilities include
management of clinically applied medical device retains and associated paper records in accordance with Client Record Retention Policies and support staffing needs.
ESSENTIAL FUNCTIONS:
• Assist PMV Investigations Coordinator with managing receipt of physical complaint product samples, in addition to corresponding with domestic and international accounts to rectify discrepancies in product receipt.
• Assist in the prioritization of complaint investigations.
• Assist in the coordination of sanitization of clinically applied medical device returns and shipment to respective Client Manufacturing facilities, as well as coordinating the investigation process with internal
• Engineering and Quality groups.
• Test and thoroughly evaluate rudimentary surgical products to determine root cause analysis within a closely monitored time frame.
• Certification with OSHA s BloodBorne Pathogens Standard 29 CFR 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies.
MINIMUM REQUIREMENTS:
Education Required: High School Diploma
Education Preferred: BS Degree in a Technical curriculum preferred or equivalent industry experience.
Minimum Experience:
• Experience in a laboratory environment and with laboratory equipment or
• academic knowledge in scientific research methods.
• Experience with medical devices preferred but not required.
Skills/Qualifications:
• Must be proficient with MS Office (with emphasis on Excel and Word).
• Time management skills.
• Critical independent thinking and timely follow up.
• Excellent written and verbal skills necessary.
• QD003425-001, Rev A
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
• Quality Assurance
• Manufacturing
• Engineering
• Research and Development
• Regulatory Affairs
• Legal
• Marketing/Sales
WORKING CONDITIONS:
Bio hazardous laboratory environment requiring use of personal protective equipment in accordance with CDC and OSHA regulations.