Full Time Quality Engineer Jobs, in Quasar Medical | Medical Device Manufacturer - Maukerja

Department: Quality

Reports To: Manager Quality

Job Summary

:The Quality Engineer is responsible for ensuring the quality and regulatory compliance of medical devices throughout the manufacturing process. This role involves developing and implementing quality assurance strategies, overseeing production processes, managing product quality, and ensuring adherence to industry standards and regulations. This will include support for new product transfers

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Essential Duties and Responsibilitie

s:Include the following. Other duties may be assigne

d.• Quality Assurance and Contro

l:- Develop, implement, and maintain quality assurance plans, procedures, and control measure

s.- Monitor and analyse production processes to detect and resolve quality issue

s.- Ensure compliance with relevant regulatory requirements, including FDA, ISO 13485, and other applicable standard

s.- Support internal and external audits and regulatory inspection

s.- Investigate and resolve product-related issues, deviations, and non-conformities, with the authority to recommend corrective and preventive action

s.- Ensure the non-conformance or quality issue is resolved and complete in a timely manne

r.- Participate in new product introductions to ensure quality is built into all products early in their life cyc

le- Support validation processes including IQ, OQ, PQ, process validation and test method validatio

n.• Process Improvemen

t:- Identify opportunities for process improvements to enhance product quality and manufacturing efficienc

y.- Lead and drive QA initiatives across the product are

as- Lead or participate in root cause analysis and corrective action plannin

g.- Support and drive cost improvement proje

ct• Customer Interactio

n:- Address customer complaints and feedback related to product qualit

y.- Work closely with customers to understand their quality requirements and ensure that products meet their specification

s.- Communicated on any potential change request of the processes to custome

r.- Provide technical support and quality-related information to customer

s.• Documentation and Reportin

g:- Maintain comprehensive records of quality control activities, inspection results, and non-conformance report

s.- Prepare and support monthly / annual quality reports to management and other stakeholder

s.- Ensure proper documentation and traceability throughout the manufacturing proces

s.• Training and Developmen

t:- Train manufacturing staff on quality standards, procedures, and best practice

s.- Promote a culture of quality and continuous improvement within the organizatio

n.
Authori

ty:• To approve process / product related forms, work instruction and procedur

es.• To approve the risk assessment fi

le.• Authorize to sign on the Certificate of Analys

is.
Education/Experience and Qualificati

• ons:Degree in Engineering or science, with 2 - 5 years of progressive Quality responsibility, preferably in medical device / pharmaceutical manufacturing. Diploma holders in Engineering or science with more than 5 years' experience in Quality may be conside
• red.Knowledge of regulatory requirements and quality standards, including FDA regulations and ISO 13485 standa
• rds.Good command of English langu
• age.Strong analytical and problem-solving skills, with the ability to troubleshoot complex iss
• ues.Able to effectively collaborate with cross-functional teams and present information clea