Sign upLog in

Analyst, Product Surveillance

KYYBA, Inc

St. Paul, MN

Apply
JOB DETAILS
SKILLS
Analysis Skills, Biology, British Standards Institute (BSI), Business Services, Consulting, Corporate Policies, Cross-Functional, Environmental Management Systems, Establish Priorities, External Audit, FDA (Food and Drug Administration), FDA Requirements, File Maintenance, Hospital, Information Technology & Information Systems, Internal Audit, International Sales, Laboratory Equipment, Legal, Manual Dexterity, Manufacturing, Medical Affairs, Medical Equipment, Office Equipment, Operations Processes, Organizational Skills, Performance Analysis, Product Management, Product Support, Product Testing, Quality Engineering, Quality Management, Regulations, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Research Laboratory, Surveillance, Technical Recruiting, Testing, Time Management, Trend Analysis, Willing to Travel
LOCATION
St. Paul, MN
POSTED
5 days ago
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 maintained. Supports inspections by regulatory agencies (e.g. FDA, TUV, BSI, etc.) as requested. Provide 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.
Work environment varies from well lighted 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.
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.
 
Location: (St. Paul,MN)
 
Disclaimer: 
Kyyba is an Equal Opportunity Employer.
Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
 
Rewards:
Medical, dental, vision
401k 
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client 
 
 
SELECT AWARDS
  • An INC 5000 company for 10 years
  • Corp! Michigan Economic Bright Spots 
  • Crain’s Detroit Business Top Staffing Service Companies in Detroit
  • TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
  • Best of MichBusiness winner in HR Wizards & Partnerships
  • Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
  • 101 Best & Brightest Companies to Work for in Michigan
 
 

About the Company

K

KYYBA, Inc

Kyyba group of companies are privately held and specialize in staff augmentation, application software and project solutions. In operation for more than 15 years, we have earned an enviable track record and reputation within all the industries we serve. Our unique processes and maturity enables us to understand the needs of the business organizations and provide business solutions that match the real and compelling needs of our customers.

Headquartered in Michigan, Kyyba has multiple office locations and we serve local, regional and national client base consisting of Fortune 500 and middle market companies. Kyyba extends the above solutions and services to a broad spectrum of industry verticals ranging from automotive, insurance, technology, financial, transportation, government and so on.

COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1998
WEBSITE
http://www.kyyba.com/