Medical Device Quality Engineer — Hybrid, CAPA & Compliance

Codon Partners Ltd.; Boston (MA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Codon Partners Ltd. is seeking an experienced Quality Engineer to support quality assurance and compliance in a medical device manufacturing environment. The role focuses on maintaining quality systems, supporting manufacturing operations, and investigations to ensure ongoing regulatory compliance.

You will collaborate with cross-functional teams on improvements and sustainable solutions. The position offers exposure to established processes and new product development activities in a hybrid

Qualifications

• Bachelor's degree in Engineering or related field.
• ≥3 years in quality engineering or QA in medical devices.
• Experience with CAPA, change control, deviations, and audits.
• Knowledge of ISO 13485 and GMP requirements.
• Familiarity with ISO 14971 risk management and FDA QMS.
• Experience applying eQMS and product development processes.

Responsibilities

• Oversee CAPA, change management and nonconformance investigations.
• Assess processes for regulatory requirements and internal procedures.
• Support administration and improvement of the eQMS.
• Review quality docs: SOPs, reports, validation records.
• Identify compliance gaps and remediation plans.
• Coordinate internal audits and regulatory inspections.
• Manage audit findings and corrective actions.
• Lead root cause investigations and action recommendations.
• Apply statistics to monitor process performance.
• Collaborate with Manufacturing, Engineering and Product teams.

Skills

CAPA management

Change control

Deviation investigations

Audit activities

Problem solving

Data-driven quality improvement

Communication

Quality documentation

Education

Bachelor's degree in Engineering or related field

Tools

eQMS

Job description

Codon Partners Ltd. is seeking an experienced Quality Engineer to support quality assurance and compliance in a medical device manufacturing environment. The role focuses on maintaining quality systems, supporting manufacturing operations, and investigations to ensure ongoing regulatory compliance.

You will collaborate with cross-functional teams on improvements and sustainable solutions. The position offers exposure to established processes and new product development activities in a hybrid