6587 - Project Administration Engineer

Project Administration Engineer Responsibilities:

Support handling customer complaints. Objectives include:

Support timely completion of product complaint investigations, in compliance with global and local procedures.

Assess incoming complaints and determine next steps needed to adequately address the complaint issue(s) in a timely manner.

Determine the appropriate level of return sample analysis needed.

Perform visual and/or functional analysis as needed.

Verify and close relevant complaints with minimal supervision.

Support inventory management of complaint samples.

Support QA personnel in writing GMP documents, and completing complaint process metrics, including second person verification (SPV) of complaints data.

Conduct PM activities in the Life Science Industry ensuring the project meets the demands of the client.

Understand Lifecycle management for Quality Applications.

Requirements:

Must be willing to work onsite in Indianapolis, IN.

Associate's degree in Engineering, Life Sciences, or a related field.

Strong computer literacy in all Microsoft Office applications.

Strong attention to detail.

High degrees of self-management and problem solving.

Ability to work under tight deadlines

Strong interpersonal skills and extremely resourceful

Additional Preferences:

Knowledge of regulatory requirements (e. g. cGMP, 21 CFR 820, ISO 13485, Canadian MDR)

Knowledge of complaint handling and quality systems; device/combination product complaint experience preferred

Veeva QualityDocs experience

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$65,296—$95,358 USD