Quality / Manufacturing Engineer

Permanent position for a Quality/Manufacturing Engineer responsible for transferring medical device processes from R&D into production.

Responsibilities

• 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.

Qualifications

• 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.