Quality Engineer-Medical Device-Only W2
: Job Details :

Job Title - Quality Engineer I - Exempt

Job Location - Santa Ana, California.

HM's Top Needs:

Education Required: Bachelor's degree in science/engineering.

Years' Experience Required: minimum 2 years.

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours

Work Location:

Do they need to be local to any MDT office and if so where? Yes, local to Santa Ana, CA or Orange County area.

Does this person need to be on site? If so, full time or part time? Flex i.e. part time on site.

Responsibilities may include the following and other duties may be assigned.

• Conducts complaint investigations for Structural Heart devices. This includes performing intial assessment to create appropriate tasks or technical assessments in the Global Complaint Handling (GCH) system, for example - DHR reviews, Manufacturing assessment, R&D assessment,etc.
• Performing thorough review of these assessments by working with cross-functional teams (like Medical Safety, Manufacturing, Operations Quality, R&D, Design Assurance and Customer Quality Teams) across multiple sites and time zones globally. Summarizing the results of these assessments into the complaint investigation summary in a timely manner to ensure timely closure of the overall event.

To be able to consistently close complaint investigations to meet weekly target volumes. Ensuring timely completion of complaint investigations to sustain a compliant timeliness metric/KPI for the entire Operating unit.

Presenting complaints on a weekly basis and escalating events that meet certain criteria. To be able to communicate complaint information across all levels in the organization.

Supporting regulatory submissions and regulatory inquiries on complaints by working closely with Customer Quality Experience Management team (CQXM) and providing complaint data as requested.

Ability to present the complaint investigation in an audit when needed.

Sushma.k

...@grovetr.com

609-###-####