Quality Engineer II – Medical Devices

About the role

Becton, Dickinson and Company (BD) is looking for a Quality Engineer II to support product development and quality system activities within a regulated medical device environment. The role ensures compliance with ISO 13485, FDA Quality System Regulations (21 CFR Part 820) and international regulatory requirements, while supporting design control, risk management and continuous quality improvement. You will work closely with cross-functional teams across the product development lifecycle.

Key responsibilities

• Support and maintain Design and Development Controls in line with ISO 13485 and FDA QSR.
• Lead or support Risk Management activities in accordance with ISO 14971.
• Take part in product development projects so that QA deliverables are completed accurately and on time.
• Create, revise and maintain controlled quality documentation such as SOPs, specifications, procedures and test methods.
• Ensure R&D and quality system processes comply with regulatory and customer requirements.
• Support continuous improvement initiatives and apply Six Sigma methodologies and quality tools.
• Provide quality system expertise and training to cross-functional teams.
• Participate in QA and quality system activities, audits and compliance initiatives, and support audits, regulatory inspections and compliance activities.
• Collaborate with engineering, manufacturing, regulatory and project teams.

Required profile

• Bachelor's degree in Mechanical Engineering, Life Sciences, Quality, Biomedical Engineering or a related discipline.
• Minimum 2 years of relevant experience in a quality role in a medical device company.
• Experience in a R&D phase-gate process and/or design transfer process.
• Experience in QA, design quality, quality systems or regulated product development environments.
• Strong problem-solving, analytical and communication skills, and ability to work in cross-functional teams and manage multiple priorities.
• Preferred: experience supporting audits, regulatory inspections and compliance activities.

Required skills

• Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QSR and medical device quality system requirements.
• Working knowledge of design controls, verification and validation, and risk management (ISO 14971).
• Experience with quality documentation, SOP development, change control and document management systems.
• Familiarity with Six Sigma, continuous improvement methodologies or quality tools is advantageous.

What we offer

• Competitive full-time compensation package and benefits.
• Paid company holidays.
• Career development opportunities.
• Company transportation provided.