Senior Quality Engineer II — MedTech Wearables

BD; Cork; On-site; EUR 95,000 - 105,000; Full time

Job summary

BD is seeking a Staff Quality Engineer II to support the development and lifecycle management of wearable injector devices. You will lead design controls, risk management, and process validation across the product lifecycle, collaborating with software, hardware, manufacturing, and suppliers to ensure quality and regulatory compliance.

The role emphasizes solving complex quality issues, driving CAPA, and delivering high-quality biologics-related device solutions that improve patient outcomes.

Qualifications

• Bachelor's degree in Engineering or related field.
• 12+ years in Quality Engineering or regulated industry.
• Strong knowledge of ISO 13485, FDA QSR, GMP.
• Understanding of design control across product lifecycle.
• Experience with statistical methods and quality tools.
• Expertise in Quality Systems, Six Sigma, validation, and FMEA.
• Broad manufacturing and development experience in regulated env.
• Analytical and problem-solving skills.
• Strong written and verbal communication; cross-functional influence.
• Leadership with ability to manage multiple projects.

Responsibilities

• Lead failure investigations and root cause analysis.
• Ensure design control and regulatory compliance throughout lifecycle.
• Review and approve product/process specifications.
• Collaborate with software, hardware, reg, and R&D teams for development.
• Define and maintain product control strategies and risk plans.
• Plan and oversee process validation and supplier qualification.
• Drive quality improvements across projects and CAPA.
• Provide quality support to manufacturing, customers, suppliers.
• Support audits and sustain corrective actions.
• Develop and improve quality systems and processes.

Skills

Quality Engineering

Medical Device

ISO 13485

FDA QSR

GMP

Design Controls

Six Sigma

FMEA

Risk Management

Root Cause

Project Management

Education

Bachelor's degree in Engineering

Job description

BD is seeking a Staff Quality Engineer II to support the development and lifecycle management of wearable injector devices. You will lead design controls, risk management, and process validation across the product lifecycle, collaborating with software, hardware, manufacturing, and suppliers to ensure quality and regulatory compliance.

The role emphasizes solving complex quality issues, driving CAPA, and delivering high-quality biologics-related device solutions that improve patient outcomes.