Global Product Surveillance Quality Associate
Req Ref No: SGMNGP31
Location: Brooklyn Park, MN
Duration: 10.5 months
Top 3 must haves: attention to detail, medical device experience, solid written and verbal communication skills
Top Technical skills needed: computer skills for word processing and complaint processing, ability to prioritize work to meet deadlines, ability to read prints and other technical documentation
Will they be working virtual? No, option to occasionally, but there will be work that needs to be done at the facility
Hours: Flexible 8 – 4:30/5 or 7 – 3:30/4
Complaint Evaluator :
This section focuses on the main purpose of the job in one to four sentences
This position is responsible for performing complaint evaluation and investigation activities, documenting results of these activities and initiating further nonconformance investigation as applicable.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Process complaint investigations:
Collect necessary complaint evaluation information
Document complaint investigation and sample evaluation results
Respond to customer complaints (written or verbal), following review by higher level specialist
Timely closure of complaint evaluations, as per procedure
Manage workflow; identify and escalate issues as needed
Perform trend reporting and escalate results for consideration of necessary actions
Participate in process improvement activities and projects
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required.
Working knowledge of FDA Quality System regulations and application of Good Manufacturing Practices.
Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures.
Solid written/verbal communication and organizational skills.
Knowledge and application of computer systems for word processing and complaint management.
Ability to work with cross-functional teams and to interact effectively with peers, management, and internal customers.
Education and/or Experience: Include the education and experience that is necessary to perform the job satisfactorily.
A minimum of an Associates Degree required in nursing, pharmacy, medical technology, engineering or scientific background (MLT, LPN, RN). Bachelor degree and /or clinical certification (MT, RN) preferred.
1-3 years work experience in a cGMP related industry or in a clinical setting.
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.