Senior Quality Operations Engineer

272753BR
Senior Quality Operations Engineer

Job Description

Provide quality oversight to validation and calibration management activities

Provide operational support for non-conformances, complaint investigations, change requests etc.

Support and provide QA oversight for all supplier management activities

Provide quality oversight to validation activities and calibration management

Provide e-compliance support to all relevant activities on site

Conduct and support investigations for non-conformances, FAAs, customer complaints etc.

Perform review/ approval and ensure adequate oversight for non-conformances & CAPAs

Support internal and external audits, be responsible for timely closure of audit CAPAs, if any.

Support QM implementation and remediation

Implement new initiatives to improve performance and efficiency of QOPs processes

Perform internal audits as per audit schedule, excluding e-compliance oversight areas

Provide operational support for product release to ensure it meets all quality and regulatory requirements

Initiate/ manage projects within QOPs and drive the completion of these projects

Provide assistance to supervisor in managing cost centre budget and forecast accuracy

Manage and provide QA oversight to supplier qualification, monitoring, deviations etc. as part of the whole supplier management process

Perform any other duties as assigned by Supervisors according to business needs

Minimum requirements

Degree in Engineering (Mechanical, Electrical, Biomedical) or Science (Physics, Chemistry, Material), or relevant discipline or equivalent

More than 5 years of experience in the medical device or pharmaceutical industry.

Very good understanding of process / equipment validation and qualification.

Good grasp on processes related to non-conformances.

Good knowledge on ISO 13485, FDA 21 CFR Part 11 and Part 820

Able to write and communicate well Very good analytical and critical thinking skills
ALCON
NON-NVS AL QUALITY ASSURANCE
Singapore
Singapore
CIBA VISION ASIAN MANUF & LOG
Quality
Full Time
Regular