No more applications are being accepted for this job
QA Complaint Associate - Indianapolis, United States - Eurofins USA PSS Insourcing Solutions
Description
Job DescriptionMonitor, triage and assign complaints timely and appropriately.
Understand the devices to support investigations as defined in associated complaint procedures.
Perform and/or lead detailed complaint investigations.
Perform examinations on returned complaint samples as applicable.
Ensure timely completion of complaint investigations.
Supports ad hoc complaint requests when necessary.
Utilize Failure Modes and Effects Analysis (FMEA), as applicable.
Utilize non-routine software tools or business systems to complete complaint investigations.
Ensure compliance with Medical Device Reporting (MDR) and other regulatory reporting requirements.
Qualifications:
Qualifications
_
Basic Minimum Qualifications:
_
Associate's degree in engineering, medical or life sciences
Strong written, oral and interpersonal skills
Strong technical writing skills
Strong attention to detail, time management, teamwork, and ability to multi-task
Ability to work in a dynamic and fast-paced environment
_
Experience Desired:
_
Previous experience with deviation and/or complaint investigation processes
Proficiency in Mocrosoft Office Suite, SAP, Trackwise, Stature, Darwin and Veeva Vault programs
Experience in Manufacturing QC, QA, Technical Services or Regulatory
Knowledge of cGMP's
Knowledge of global medical devices and combination product regulations (e.g., 21CFR820, 21CFR Part 4, Part 11, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAl, TGA, ANVISA)
Additional Information
Position is
full-time, Monday - Friday.
Candidates currently living within a commutable distance of
Indianapolis
, IN
are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
Life and disability insurance
401(k) with company match
Paid vacation and holidays
#LI-EB1
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
#J-18808-Ljbffr