Quality Assurance Manager - Saudi nationals only📣 Job Ad

in Alcon

about 2 hours ago

	Contract Type	Full-time
	Workplace type	On-site
	Location	Makkah

About the Role

Alcon, a global leader in eye care, is seeking a dedicated Quality Assurance Manager for Saudi nationals to establish and lead its Quality function in Saudi Arabia. This role is crucial for ensuring full compliance with global and local regulatory requirements within a rapidly growing market. The position involves building the Quality System from the ground up, shaping the local team, and partnering with leadership to achieve operational excellence. This is an opportunity to embed a strong quality culture and contribute to Alcon's regional growth.

Key Responsibilities

Collaborate with cross-functional teams and leadership to embed a strong Quality Culture and ensure compliance with ISO 13485, GDP, EU-MDR (where applicable), and Saudi regulatory requirements.
Act as the Quality Management Representative and, where required, the Responsible Person for wholesale distribution, ensuring adherence to local and international standards.
Lead quality operations including batch documentation review, product release, storage and distribution oversight, supplier qualification, and management of non-conformances and CAPAs.
Prepare for and manage external inspections by Health Authorities and Notified Bodies, ensuring timely closure of audit findings and robust CAPA implementation.
Drive vigilance and technovigilance activities, ensuring accurate and timely reporting to local authorities and acting as the affiliate representative when required.

Qualifications and Experience

Bachelor's degree in a Scientific or Engineering discipline.
A minimum of 5 years of Quality experience within the medical device or pharmaceutical industry.
Demonstrated strong knowledge of ISO 13485 and 21 CFR Part 820.
Proven experience with vigilance/technovigilance processes and strict reporting requirements.
Familiarity with Saudi regulatory requirements is highly preferred.

Required Skills and Competencies

Expertise in Quality Assurance principles and practices.
Proficiency in ISO 13485, Good Distribution Practice (GDP), and EU-MDR (where applicable).
Strong understanding of Saudi regulatory requirements.
Experience in Quality Management systems.
Skills in batch documentation review and product release processes.
Competence in storage and distribution oversight.
Ability to conduct supplier qualification and manage non-conformances.
Experience with Corrective and Preventive Actions (CAPA) implementation.
Capability to manage Health Authority and Notified Body inspections.
Proficiency in vigilance and technovigilance activities.
Knowledge of 21 CFR Part 820.
Strong capability working with digital systems; SAP experience is an advantage.
Excellent communication skills for operating in an international environment.
Demonstrated flexibility, adaptability, and precision.
Ability to work autonomously in a fast-paced, evolving environment.
People management experience is an advantage.

Role Context and Location

This role is based in Jeddah, Makkah, Saudi Arabia, and is a full-time position. It offers the opportunity to build an affiliate and Quality function from the ground up, shaping processes, systems, and team structure. The position is within a dynamic, expanding market with significant career growth potential and exposure to regional leadership. The work environment is collaborative and international, empowering individuals to take ownership and drive impact. A minimum of 5-10 years of experience is required.

Please note that for this role, Saudi Nationality and an English CV are required.

Requirements

For Saudis Only
Requires 5-10 Years experience

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