Quality / Manufacturing Engineer

Description

Permanent position for a Quality/Manufacturing Engineer responsible for transferring medical device processes from R&D into production.
Maintain QMS compliance to FDA 21 CFR Part 820 (QMSR), ISO 13485 and MDSAP, and support internal, supplier, customer and regulatory audits.
Plan and execute IQ/OQ/PQ validations, and write the associated protocols, reports and specifications.
Lead PFMEA/DFMEA and risk analysis activities and implement risk controls.
Investigate deviations, nonconformances, complaints and product failures, and drive root cause (5-Why, Fishbone, FTA) through CAPA closure.
Improve process yield, throughput and cost using SPC, data analysis, time studies and product costing.
Qualify and monitor suppliers, and review supplier corrective action responses.
Write work instructions, inspection methods and training materials, and maintain DMR/DHR documentation.
Participate in design reviews, change assessments, Management Review and continuous improvement projects.
Option to work from home 1 day per week.

BS in Engineering (Mechanical, Biomedical, Industrial or related discipline).
Minimum 5 years of experience in quality and/or manufacturing engineering for medical devices.
Experience with process validation (IQ/OQ/PQ) and R&D-to-production transfers.
Working knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485 and MDSAP.
Experience with PFMEA/DFMEA, CAPA and nonconformance investigations.
Proficiency with root cause analysis methods and SPC.
Experience with supplier qualification, supplier audits and supplier corrective actions.
Experience with DHR/DMR and controlled quality documentation.
Ability to travel up to 10% to suppliers and customers.

Click Apply to job below, or call

(973) 490-7000 and ask for me,

Allan Berman.

Job #:

22230-AB1