Analyst, Product Surveillance

Job Title: (Analyst, Product Surveillance)


About Kyyba:
Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.
At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.


Job Description


This position will analyze and submit complaints and/or investigate returned products from the field (some biohazard as they are used in surgery).

• 4-year degree science background; bio, chem, life sciences, etc.

• Complaint handling, investigation of product performance experience nice to have

• Highly organized – able to prioritize well

• Cross functional communication

• Position is contract to hire

• 100% onsite position – candidates must be local to MN
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 pertaining to product experiences for ***. 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, 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).

The other role of the Product Performance Analyst I 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 I 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.

Main 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 in a timely manner. 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…