Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Find Jobs
Find Jobs Near You – Available Work in Your Location
Find & Apply For Manufacturing Engineer Jobs in Flagtown, New Jersey
Browse jobs from a variety of sources below, sorted with the most recently published, nearest to the top. Click the title to view more information and apply online.
Skip to job details
Now viewing: Design Quality Engineer
ES
Excelon Solutions
Design Quality Engineer
Review key factors to help you decide if the role fits your goals.
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
71
out of 100
Average of individual scores
Job Description
Design Quality Engineer at Excelon Solutions Design Quality Engineer at Excelon Solutions in Flagtown, New Jersey Posted in about 15 hours ago.
Type:
full-time
Title:
Design Quality Engineer Location:
Raritan, NJ - Onsite Project Duration - 2+
Years JD:
Hands-on experience in medical device design and development. Hands-on experience with FDA-regulated Design Controls, Change Controls, and New Product Development (NPD). Hands-on experience in Component Qualification and Process Validation activities. Strong knowledge of
ISO 13485, FDA 21 CFR
Part 820, EU MDR, and
ISO 14971
Risk Management. Lead and maintain Risk Management Files including Hazard Analysis and FMEAs. Review and approve DHF deliverables and quality documentation. Review and approve verification, validation, and design transfer deliverables. Participate in Design Reviews to ensure quality, regulatory, and product requirements are met. Review and approve Component Qualification, IQ, OQ, PQ, TMV, and Gage R&R studies. Assess product, process, and supplier changes for quality and regulatory impact. Participate in CAPA, and nonconformance investigations. Analyze quality metrics and complaint trends to drive continuous improvement. Serve as a Design Quality SME during audits, inspections, and design reviews.