Supplier Quality Engineer: Medical Device Quality & Compliance

ATR International; North Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

ATR International seeks a Supplier Quality Engineer to oversee finished goods contract manufacturing for Robotics Surgical Technologies. You will manage QMS-related supplier activities, lead SCRs, PPAPs, quality plans and FMEAs with contract manufacturers to deliver reliable, cost-effective solutions.

State-of-the-art collaboration with engineering and manufacturing will ensure compliance with quality standards and continuous improvement. Experience with ISO 13485 and 21 CFR 820 is expected.

Qualifications

• Bachelor’s Degree in Engineering/Scientific/Electronic or technical field.
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities

• Develops, maintains quality standards and protocols for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Implements inspection and testing methods for product and equipment; conducts QA tests and statistical analyses.

Skills

Lead and manage supplier changes/SCRs

CM/Supplier quality systems

Medical device quality standards (ISO

Education

Bachelor’s Degree in Engineering/Scientific/Technical field

4+ years experience or 2+ years with advanced degree

Job description

ATR International seeks a Supplier Quality Engineer to oversee finished goods contract manufacturing for Robotics Surgical Technologies. You will manage QMS-related supplier activities, lead SCRs, PPAPs, quality plans and FMEAs with contract manufacturers to deliver reliable, cost-effective solutions.

State-of-the-art collaboration with engineering and manufacturing will ensure compliance with quality standards and continuous improvement. Experience with ISO 13485 and 21 CFR 820 is expected.