The Fountain Group
Analyst, Product Surveillance
The Fountain Group, Saint Paul, Minnesota, United States, 55199
Currently I have an opening for a
Product Surveillance Analyst
located in
St. Paul, MN.
Details for the position are as follows:
Job Description:
Managing product experience investigations and all activities pertaining to product experiences for Client.
Receiving and investigating reports of worldwide product experiences/events on a variety of products, entering information into the complaint database, participating in cross-functional projects, facilitating investigation findings of product issues, assist with internal and external audits, and providing comprehensive reports, analysis, and insights on product experiences, and may extract data from the complaint database to various teams (e.g. Regulatory, Quality Engineering).
Perform evaluations of returned products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings, operating, and maintaining the Product Performance Laboratory and equipment, and collecting and evaluating analysis data and entering it into the complaint database.
May assist in the trending of complaint data as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department.
Initiates and manages the product experience file, maintains accurate entry of product experiences in the database, and triages new product experience report files from time to time.
Uses procedures, judgment, and experience to determine appropriate testing of returned products with occasional support; can ascertain when additional support is needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues).
Maintains accurate entry of product experiences in database, records condition of returned products including observations and photographs, interprets technical product specifications, Device History Records, or measurements obtained; and always utilizes safe biohazard and chemical handling practices.
Communicates verbally and in writing both internally and externally regarding information needed specific to product experiences (e.g. physicians, hospital personnel, sales representatives, international offices).
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Independently assesses the product experience to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities).
Independently assesses the complaint to determine if an escalation is required.
Ensures accurate department procedures and work instructions are maintained.
Supports inspections by regulatory agencies (e.g. FDA, TUV, BSI, etc.) as requested.
Provide support to Legal Department regarding product complaints.
Bachelor’s degree in the life sciences required – recent bachelors are welcome to apply!
0.5-3 years of experience in the medical device or pharmaceutical industry supporting QA, complaints, investigations, or quality related documentation.
Must have experience in an academic laboratory setting within microbiology, chemistry, biochemistry, or molecular biology fields.
Technical Information:
Pay: $25-31 hourly, depending on experience level
Onsite, M-F, 8am-5pm
11-month, contract-to-hire position
#J-18808-Ljbffr
Product Surveillance Analyst
located in
St. Paul, MN.
Details for the position are as follows:
Job Description:
Managing product experience investigations and all activities pertaining to product experiences for Client.
Receiving and investigating reports of worldwide product experiences/events on a variety of products, entering information into the complaint database, participating in cross-functional projects, facilitating investigation findings of product issues, assist with internal and external audits, and providing comprehensive reports, analysis, and insights on product experiences, and may extract data from the complaint database to various teams (e.g. Regulatory, Quality Engineering).
Perform evaluations of returned products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings, operating, and maintaining the Product Performance Laboratory and equipment, and collecting and evaluating analysis data and entering it into the complaint database.
May assist in the trending of complaint data as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department.
Initiates and manages the product experience file, maintains accurate entry of product experiences in the database, and triages new product experience report files from time to time.
Uses procedures, judgment, and experience to determine appropriate testing of returned products with occasional support; can ascertain when additional support is needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues).
Maintains accurate entry of product experiences in database, records condition of returned products including observations and photographs, interprets technical product specifications, Device History Records, or measurements obtained; and always utilizes safe biohazard and chemical handling practices.
Communicates verbally and in writing both internally and externally regarding information needed specific to product experiences (e.g. physicians, hospital personnel, sales representatives, international offices).
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Independently assesses the product experience to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities).
Independently assesses the complaint to determine if an escalation is required.
Ensures accurate department procedures and work instructions are maintained.
Supports inspections by regulatory agencies (e.g. FDA, TUV, BSI, etc.) as requested.
Provide support to Legal Department regarding product complaints.
Bachelor’s degree in the life sciences required – recent bachelors are welcome to apply!
0.5-3 years of experience in the medical device or pharmaceutical industry supporting QA, complaints, investigations, or quality related documentation.
Must have experience in an academic laboratory setting within microbiology, chemistry, biochemistry, or molecular biology fields.
Technical Information:
Pay: $25-31 hourly, depending on experience level
Onsite, M-F, 8am-5pm
11-month, contract-to-hire position
#J-18808-Ljbffr