Quality Assurance Engineer – Medical Technology

About the role

PurposeBD is seeking a Quality Assurance Engineer to ensure that our medical device products meet the highest quality and regulatory standards. You will work closely with manufacturing, engineering, and supplier teams to drive continuous improvement and compliance.

Key responsibilities

• Review inspection criteria, methods and procedures to guarantee economic yet acceptable quality levels.
• Investigate product complaints, coordinate corrective actions, and document resolutions.
• Support cGMP compliance during product and process validations, transfers, and audits.
• Monitor quality trends, conduct statistical investigations, and report findings with recommendations.
• Perform and review IQ, OQ, and PQ for manufacturing, packaging, test and inspection equipment.
• Audit processes against BD procedures, specifications, and regulatory requirements.
• Provide technical quality support to suppliers, manufacturing engineering, and customer service.
• Review and approve documentation related to product quality, such as test procedures and specifications.

Required profile

• Experience in quality assurance within a regulated medical device or pharmaceutical environment.
• Strong understanding of cGMP, validation protocols (IQ/OQ/PQ) and audit practices.
• Ability to analyze data, identify trends, and drive corrective actions.
• Excellent communication skills to interact with cross‑functional teams and external partners.

Required skills

• cGMP compliance
• IQ/OQ/PQ validation
• Statistical analysis of quality data
• Audit and regulatory documentation review

What we offer

• Opportunity to work on cutting‑edge medical technology products.
• Collaborative environment with multidisciplinary teams.
• Professional development and continuous improvement initiatives.