Analyst, Product Surveillance

Analyst, Product Surveillance

Location: St. Paul, MN

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract (Contract-to-Hire)
• Contract Duration: 6 months
• Pay Rate: $32.03 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

Under the direction of management, the Product Performance Analyst may perform two different functions. The first consists of managing product experience investigations and all activities related to product experiences for the client. This includes, but is not limited to: 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, assisting 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).

The other role of the Product Performance Analyst is to 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.

The Product Performance Analyst 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.

Key Responsibilities

• Initiates and manages the product experience file.
• Maintains accurate entry of product experiences in the database.
• Triages new product experience report files from time to time.
• Investigates events promptly.
• 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.
• Provides support to Legal Department regarding product complaints.
• Works collaboratively with cross-functional groups (e.g., QEs, R&D, medical affairs, medical education, etc.).
• May coordinate product testing/analysis with other departments and external consultants.
• May track returned products within the database, as appropriate.
• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Performs other related duties and responsibilities, on occasion, as assigned.

Required Skills

• Highly organized able to prioritize well
• Cross-functional communication skills

Preferred Skills

• Complaint handling and investigation of product performance experience

Education Requirements

• 4-year degree with a science background (biology, chemistry, life sciences, or related field)

Work Environment / Physical Requirements

• Work environment varies from well-lit office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
• Activities require a significant amount of sitting in front of a computer monitor, with some standing and walking.
• Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.
• Performs tasks that regularly require good correctable vision and hand/eye coordination.
• Activities also require significant use of voice and hearing for discussions with other employees.
• This position will analyze and submit complaints and/or investigate returned products from the field (some biohazard, as they are used in surgery).

Important Notes

• This is a 100% onsite position candidates must be local to St. Paul, MN.

About the Client

This client is a leading healthcare innovator dedicated to improving lives worldwide through a diverse portfolio of medical devices, diagnostics, and nutrition products, employing professionals across clinical, quality, regulatory, engineering, and research disciplines at facilities across the globe.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-08219