Onsite Medical Device Supplier Quality Engineer II

Planet Pharma; North Haven (CT); On-site; USD 80,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a Supplier Qual Engineer II to manage supplier quality for Robotics Surgical Technologies. The role focuses on QMS, supplier changes, PPAP, and FMEA across CM suppliers onsite in North Haven, CT.

Requirements include a Bachelor’s degree in engineering or scientific field and 4+ years of relevant experience; on-site 40 hrs/week. ISO 13485/21 CFR 820 familiarity preferred.

Qualifications

• Experience in supplier quality for medical devices or pharma-related manufacturing.
• Bachelor’s degree in engineering or scientific field with relevant experience.
• Familiarity with ISO 13485 and 21 CFR 820 is a plus.

Responsibilities

• Qualifies suppliers according to company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through the manufacturing cycle and resolves supplier-related problems.
• Develops auditing schedules to ensure GMP and quality standards are met.

Skills

SCR process

QMS systems

FMEA

Education

Bachelor’s Degree in Engineering

Tools

MSA

PPAP

Job description

Planet Pharma is seeking a Supplier Qual Engineer II to manage supplier quality for Robotics Surgical Technologies. The role focuses on QMS, supplier changes, PPAP, and FMEA across CM suppliers onsite in North Haven, CT.

Requirements include a Bachelor’s degree in engineering or scientific field and 4+ years of relevant experience; on-site 40 hrs/week. ISO 13485/21 CFR 820 familiarity preferred.