The Complaints Quality Engineer will perform post-market safety and surveillance activities. He/she will implement the complaint’s process with a concentration on signal assessment and investigations of Safety Issues and Quality Trend Events. The Quality Engineer will evaluate Signal Analysis/Detection Data, and interface with the complaints data analytics team. The role also includes assessing potential Safety Issues/Product Quality Events against all known PMS Data sets with the intent of confirming the issues or event. The Quality Engineer will also determine root cause of any issues or events.
The Complaints Quality Engineer will be responsible for the following:
- Work cross functionally with the R&D, Operations, Marketing and Medical team to confirm investigations or conducted.
- Post-market safety and surveillance activities including trend analyses, signal assessments and product investigations.
- Handle the complaints process from start to finish.
- Review signal analysis and detection data focusing on trends, triggers and control limits.
- Perform issue investigations to understand root causes, risk and impacts.
(li)Minimum of a Bachelor’s degree is required; engineering degree is preferable or other technical degree. Master’s degree a plus.(/li)
(li)2 years of experience required in a medical device/diagnostic or pharmaceutical company is required.(/li)
(li)Root cause analysis experience required as well as strong problem solving skills.(/li)
(li)Post-market surveillance experience strongly preferred.(/li)
(li)QSR and ISO quality requirements are strongly preferred.(/li)
(li)Knowledge of process and design tools a plus as well as Green or Black Belt training.(/li)
(li)Excellent written and oral communication and interpersonal relationship skills across all levels are required.(/li)
(li)Position may require up to 10% domestic travel and a small chance of international travel. (/li)
(div)(strong)About Intuitive Technology Solutions: (/strong)(/div)
(div)(em)Intuitive Technology Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences. We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions; however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.(/em)(/div)
(div)(em)At Intuitive Technology Solutions we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life. This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job. As a result, Intuitive Technology Solutions is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent. Intuitive Technology Solutions is an equal opportunity employer. (/em)(/div)
TechUSA - 21 months ago