We are looking for a Quality/Testing Engineer I. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements to optimize product development, internal and external device manufacturing, and device distribution.
QUALIFICATIONS:
- Perform testing, assess results, and document routine complaint product device evaluations in support of complaint investigations including dimensional and functional analysis.
- Perform analysis in No Product Return Evaluations by utilizing multiple data inputs including technical review of device history records (DHR review), in support of complaint investigations
- Collaborate with other engineers on non-routine testing in support of failure investigation and root cause analysis.
- Plan, organize, and prioritize complaint investigation activities based on complaint closure and reportability timelines.
- Generate weekly complaint reports to provide data for weekly production meetings.
- Organize and track complaint product returns and investigational follow-up inquiries related to product investigations in partnership with complaint handlers.
- Perform queries on historical complaint data to support complaint investigations.
- Collaborate with other Engineers in preliminary complaint product evaluations to determine standard or non-routine device failures. Document, communicate, and escalate results, as applicable.
SKILLS
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment required
EDUCATION and EXPERIENCE
Bachelor s degree in scientific or engineering field, and previous quality compliance and medical device (cardiovascular, endovascular, or other surgical products), healthcare, or a related en