Staff Quality Engineer II

Becton Dickinson; South Dublin; On-site; EUR 95,000 - 105,000; Full time

Job summary

BD in Dublin South seeks a Staff Quality Engineer II to lead design controls, risk management, process validation, and CAPA across wearable injector devices. You will partner with software, hardware, manufacturing, regulatory and R&D teams to support product development, validation activities, and lifecycle improvements, ensuring ISO 13485, FDA QSR compliance and high patient safety standards.

This role reports to the Senior Manager of Quality Engineering and requires strong analytical and

Qualifications

• Bachelor's degree in Engineering or related field.
• 12+ years in Quality Engineering in medical devices or pharmaceutical setting.
• Knowledge of ISO 13485, FDA QSR, GMP and design control lifecycle.
• Experience with statistical methods and quality tools.

Responsibilities

• Lead failure investigations, root cause analysis, and CAPA.
• Ensure design controls and quality standards across product lifecycle.
• Review and approve product/process/test method specifications.
• Collaborate with software, hardware, manufacturing, regulatory and R&D teams.
• Plan/execute validation, supplier qualification, and risk mitigation.
• Drive continuous improvement in product quality and performance.

Skills

Design controls

Risk management

Process validation

Root cause analysis

Measurement systems analysis

Design verification

Regulatory compliance

Cross-functional collaboration

Statistical methods

Six Sigma

FMEA

Education

Bachelor's degree in Engineering

Tools

CAPA systems

Quality Systems

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. It’s a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills Optional Skills

Primary Work Location IRL BD and CO Dublin South

Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information €75,900.00 - €115,725.00 EUR Annual BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.