Quality Engineer

Job Summary

We're looking for an experienced Quality Engineer to join our team and play a key role in ensuring compliance, product quality, and manufacturing excellence within a regulated medical device environment.

Key Responsibilities:

Lead deviation investigations, root cause analysis, and CAPA implementation.

✔ Provide quality oversight for process validation, equipment qualification, and manufacturing activities.

✔ Review and approve GMP/QMS documentation, SOPs, validation protocols, reports, and change controls.

✔ Support internal, customer, and regulatory audits while maintaining inspection readiness.

✔ Collaborate with Manufacturing, Engineering, and QA teams to drive continuous improvement and compliance.

✔ Ensure compliance with FDA, ISO 13485, cGMP, and applicable regulatory requirements.

Requirements:

✅ Bachelor's degree in Mechanical Engineering, Life Sciences, or a related discipline.

✅ 4+ years of Quality Engineering/Quality Assurance experience in the Medical Device industry.

✅ Strong knowledge of cGMP, FDA regulations, ISO 13485, risk management (FMEA), validation, CAPA, and QMS.

✅ Excellent problem-solving, communication, and cross-functional collaboration skills.

📩 Interested candidates can share their resume at: yasira@proximatetech.com
Or DM for more details.