Senior Quality Engineer, Medical Devices & CAPA Lead

BioTalent; Wilmington (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

BioTalent is seeking a Senior Quality Engineer to strengthen quality systems across CAPA, supplier quality, complaints, audits, validation, and risk management. You will drive continuous improvement to ensure product quality and patient safety throughout the lifecycle.

The ideal candidate brings 5+ years of regulated quality engineering experience in medical devices, working with CAPA, audits, and Design Controls within FDA/ISO 13485 environments.

Qualifications

• 5+ years of Quality Engineering experience in medical devices or regulated manufacturing.
• Experience with CAPA, investigations, supplier quality, audits, and quality systems.
• Experience in FDA and ISO 13485 regulated environments.
• Familiarity with risk management, validation activities, and design controls.
• Bachelor’s degree in Engineering, Science, or related discipline preferred.

Responsibilities

• Lead CAPA investigations, root cause analysis, and corrective actions.
• Support supplier quality activities, audits, and corrective actions.
• Investigate complaints, nonconformances, and product quality issues.
• Maintain compliance with FDA regulations, ISO 13485 requirements, and internal quality systems.
• Participate in audits with internal, supplier, customer, and regulatory stakeholders.
• Support risk management, validation, and continuous improvement initiatives.
• Collaborate with Manufacturing, Engineering, Operations, and Regulatory teams to resolve quality challenges.

Skills

CAPA investigations/root cause

Root cause analysis

Supplier quality

Audits

Quality systems

Risk management

Validation

Design Controls

Education

Bachelor’s degree in Engineering/Science or related discipline

Job description

BioTalent is seeking a Senior Quality Engineer to strengthen quality systems across CAPA, supplier quality, complaints, audits, validation, and risk management. You will drive continuous improvement to ensure product quality and patient safety throughout the lifecycle.

The ideal candidate brings 5+ years of regulated quality engineering experience in medical devices, working with CAPA, audits, and Design Controls within FDA/ISO 13485 environments.