About the Role

We are looking for a Quality Assurance Engineer to support product development and quality system activities within a regulated medical device environment.

In this role, you will ensure 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 initiatives.

You will work closely with cross-functional teams throughout the product development lifecycle to ensure quality and compliance are built into every stage of the process. This role aligns with BD's focus on maintaining robust quality systems, design controls, and regulatory compliance.

What You'll Do

Support and maintain Design and Development Controls in compliance with ISO 13485 and FDA Quality System Regulations.
Lead or support Risk Management activities in accordance with ISO 14971.
Participate in product development projects, ensuring quality assurance deliverables are completed accurately and on time.
Create, revise, and maintain controlled quality documentation, including SOPs, specifications, procedures, and test methods.
Ensure compliance of R&D and quality system processes with applicable regulatory and customer requirements.
Support continuous improvement initiatives to strengthen quality system effectiveness and operational excellence.
Apply Six Sigma methodologies and quality tools to improve product development processes.
Provide quality system expertise and training to cross-functional teams.
Participate in ongoing Quality Assurance and Quality Systems activities, audits, and compliance initiatives.
Collaborate with engineering, manufacturing, regulatory, and project teams to ensure successful product development and lifecycle management.

Job Requirements

Bachelor's Degree in Mechanical Engineering, Life Sciences, Quality, Biomedical Engineering, or a related discipline.
Minimum 2 years relevant experience in a quality role in a medical device company
Experience in a R&D Phase-Gate development process and/or design transfer process
Experience in Quality Assurance, Design Quality, Quality Systems, or regulated product development environments.
Strong knowledge of ISO 13485, FDA 21 CFR Part820/QSR, and medical device quality system requirements.
Working knowledge of Design Controls, Verification & 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.
Strong problem-solving, analytical, and communication skills.
Ability to work effectively in cross-functional teams and manage multiple priorities.
Experience supporting audits, regulatory inspections, and compliance activities is preferred.

What's In It For You

Competitive full‑time compensation package and benefits
Paid company holidays (public holidays, rest days, etc.)
Opportunities for career development and growth
Convenient company transportation provided

Quality Engineer II