Staff Quality Engineer II

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

Benefits offered by this job

Benefits

Job summary

BD in Ireland is seeking a Staff Quality Engineer II to support the development and lifecycle of wearable injector devices, partnering across software, hardware, and manufacturing. You will lead design controls, risk management, validation, and CAPA activities to ensure compliant, high-quality products that improve patient outcomes.

You will work with cross-functional teams to drive risk assessments, product control strategies, and continuous improvement initiatives across the product lifecycle.

Qualifications

• Bachelor's degree in Engineering or related scientific discipline.
• 12+ years of Quality Engineering or regulated industry experience.
• Strong knowledge of ISO 13485, FDA QSR, and GMP requirements.
• Experience applying design controls and risk management.
• Experience with statistical methods and quality tools.

Responsibilities

• Lead failure investigations and root cause analysis for quality issues.
• Ensure compliance with design control requirements and regulatory standards.
• Review and approve product, process, and test method specifications.
• Collaborate with software, hardware, manufacturing, regulatory and R&D teams.
• Define and maintain product control strategies and risk mitigation plans.
• Plan and oversee process validation and supplier qualification.
• Drive continuous improvement and quality reviews across projects.
• Support audits and CAPA implementation with cross-functional teams.

Skills

Quality Engineering

Six Sigma

FMEA/Risk Management

Design Controls

Statistical Methods

Regulatory Compliance

Education

Bachelor's degree in Engineering

Job description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Our vision for BioPharma Systems (BPS) at BD BioPharma Systems (BPS) is uniquely positioned to enable the transition to more biologics, including GLP-1 treatments, and capitalize on the large growth potential of pharmaceutical industry trends. Through proven drug-device leadership, industrial scale and patient-centric technologies, we can help biopharma partners launch faster, grow reliably and improve outcomes.

About the role

As a Staff Quality Engineer II, you will play a key role in supporting the development and lifecycle management of innovative wearable injector combination medical devices featuring complex electro-mechanical drug delivery systems. Reporting to the Senior Manager of Quality Engineering, you will apply your expertise in design controls, risk management, process validation, root cause analysis, measurement systems analysis, and design verification to ensure products meet the highest standards of quality, safety, and regulatory compliance. Working across the full product lifecycle-from concept and development through launch and post-market support-you will help drive quality excellence while contributing to the successful delivery of new technologies that improve patient outcomes. In this highly collaborative role, you will partner with cross-functional teams including software, hardware, manufacturing, and supplier partners to support product development, hardware/software integration, supplier qualification, and manufacturing readiness activities. You will lead quality-focused initiatives such as failure investigations, risk assessments, quality reviews, audit support, process validation, and continuous improvement projects. The successful candidate will be a proactive problem solver with strong analytical skills, capable of working independently, influencing stakeholders, and ensuring compliance with global quality standards while supporting both internal teams and customer-facing quality activities.

Main responsibilities will include:

• Lead and support failure investigations, root cause analysis, and problem-solving activities for non-conforming products and quality issues.
• Ensure compliance with design control requirements, quality standards, regulatory expectations, and global Quality Engineering procedures throughout the product lifecycle.
• Review and approve new and updated product, process, performance, and test method specifications from a Quality Engineering perspective.
• Partner with software, hardware, manufacturing, regulatory, and R&D teams to support product development, electro-mechanical integration, and successful product launches.
• Define and maintain product control strategies, lead risk management activities, and implement effective risk mitigation plans.
• Plan, execute, and oversee process validation, supplier qualification, and test method evaluation activities to ensure product quality and reliability.
• Drive quality excellence across development projects, including study design, data analysis, interpretation, reporting, and quality reviews.
• Provide technical quality support to manufacturing sites, customers, suppliers, and cross-functional teams to resolve issues and ensure ongoing compliance.
• Support internal, customer, and regulatory audits, ensuring effective corrective and preventive actions (CAPA) are implemented and sustained.
• Develop and improve quality systems, processes, and procedures while driving continuous improvement initiatives to enhance product quality, customer experience, and business performance.

About you

• Bachelor's degree in Engineering or a related scientific discipline.
• 12+ years of experience in Quality Engineering, Medical Device, Pharmaceutical, or a closely related regulated industry.
• Strong knowledge of medical device and quality regulations, including ISO 13485, FDA QSR, and GMP requirements.
• Solid understanding and practical application of design control principles throughout the product development lifecycle.
• Experience applying statistical methods and quality tools to support product quality, process improvement, and data-driven decision-making.
• Proven expertise in Quality Systems, Six Sigma methodologies, validation activities, and FMEA/Risk Management processes.
• Broad experience in manufacturing, product development, project management, and engineering within a regulated environment.
• Excellent analytical and problem-solving skills, with the ability to investigate complex issues and implement effective solutions.
• Strong written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams and influence stakeholders at all levels.
• Demonstrated leadership capability with the ability to manage multiple projects simultaneously, work independently, and guide team members in a fast-paced environment.

Salary €95K - €105K + Benefits

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.