Quality Manager Job Application

Lead and manage the entire Quality Management System (QMS) to ensure compliance with ISO 13485, ISO 3826, MDR, and other global regulatory standards.
Develop, validate, and implement Standard Operating Procedures (SOPs), ensuring alignment with regulatory and production goals.
Oversee QA and QC teams, providing mentorship and fostering a culture of continuous improvement.
Take charge of internal and external audits (regulatory and customer audits) and ensure readiness and compliance at all times.
Conduct risk assessments and develop strategies to address gaps in quality systems.
Coordinate with suppliers to ensure adherence to quality requirements, including supplier audits and performance evaluations.
Ensure smooth functioning of documentation processes, including batch records, CAPA, deviations, and validations.
Work closely with production and R&D teams to ensure product quality and compliance during scale-up.
Identify and recruit QA officers and QC executives, conducting interviews and onboarding to build a strong team.

Proven experience (10+ years) in QA/QC, preferably in biotech, biopharma, or medical devices.
Expertise in regulatory standards such as ISO 13485, EU MDR, and USFDA QSR (CFR Part 820).
Strong leadership and team management skills.
Ability to handle high-pressure situations, especially during audits and production scale-up.
Excellent analytical, problem-solving, and communication skills.
Track record of successfully implementing QMS in a fast-paced environment.