Commercial Quality Senior Specialist MEA

About the role

J&J MedTech is recruiting a Commercial Quality Senior Specialist for the Middle East and Africa (MEA) region, reporting to the Manager Commercial Quality and based in Cairo, Egypt. The role oversees Quality Management Systems and compliance for Commercial Quality MedTech, acts as the local point of contact on quality matters, and liaises with multiple quality organizations to resolve quality issues. It also supports product launches and continuous improvement of quality, cost and time.

Key responsibilities

• Drive improvements in purchasing controls (supplier, distributor and POLO management), samples management, equipment and computer systems validation
• Support quality systems including CAPA, document management, change control, training management, preventative maintenance and quality agreements
• Support Quality Management Reviews and internal and corporate audits, as well as logistics and transportation inspections
• Proactively identify and mitigate compliance risks through metrics reporting, internal audits and compliance programs
• Execute and support Field Actions according to J&J standards and local health authority requirements
• Oversee product quality complaints and manage change control records in the e-system
• Ensure timely, accurate metrics and reports and support departmental goals

Required profile

• Bachelor's or Master's degree in Bioscience, Engineering, Business or an equivalent field
• 5-7 years of experience in quality roles in the medical device industry, or in a quality/regulatory function
• Experience interfacing with global regulatory agencies and notified bodies
• Fluent in English
• Strong communication, collaboration and influence skills, with accountability and adaptability in a complex organization

Required skills

• Quality Management Systems (QMS)
• Preferred: audit management, compliance management, issue escalation, problem solving, quality standards and regulatory environment