Senior Quality Engineer

BioTalent; Wilmington (MA); In loco; USD 110.000 - 165.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CAPA investigations/root cause

Root cause analysis

Supplier quality

Audits

Quality systems

Risk management

Validation

Design Controls

Formazione

Bachelor’s degree in Engineering/Science or related discipline

Descrizione del lavoro

Senior Quality Engineer | Medical Device

I'm partnering with a medical device manufacturer seeking a Senior Quality Engineer to support and improve quality systems across CAPA, supplier quality, complaint handling, audits, validation, risk management, and continuous improvement initiatives. This role plays a key part in ensuring product quality, regulatory compliance, and patient safety throughout the product lifecycle.

Responsibilities

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

What We're Looking For

• 5+ years of Quality Engineering experience within the medical device or other regulated manufacturing industry.
• Experience with CAPA, complaint investigations, supplier quality, audits, and quality systems.
• Experience working within FDA and/or ISO 13485 regulated environments.
• Familiarity with risk management, validation activities, and Design Controls.
• Bachelor's degree in Engineering, Science, or a related discipline preferred.