As a Quality Engineer, you will be responsible for ensuring that products meet established standards of acceptability.
This role involves focusing on the quality management system to ensure that products and processes comply with defined standards and regulations.
Qualifications & experience:Candidates must possess at least a bachelor's degree in engineering, Science, or a related field.
Minimum of 2 years of work experience in a related field.
Fresh graduates are encouraged to apply.
Technical experience within the areas of medical device and Quality Management Systems.
Experience in auditing, inspections, and quality assurance.
Strong understanding of statistical analysis and process improvement methodologies.
Excellent communication and interpersonal skills.
Key Responsibilities:Oversee, plan, coordinate, and organise day-to-day activities of quality staff in the acceptance of incoming inventory inspections, outgoing inspections and in production inspections; and / or DHR compilation / archival / retrieval; maintain documentation as required.
Supervise, coach, and mentor team members/ subordinates, prioritise and assign tasks to ensure that the team's resources are used effectively and that work schedules and targets are met.
Manage quality matrices - Non-conformance (NCMR), Supplier Corrective Action Request (SCAR), Customer Complaint, Corrective and Preventive Action (CAPA).
Drive the CAPA process and follow through root cause analysis and CA implementation.
Prepare investigation report as required.
Compile monthly quality performance indices, report, and trending data.
Coordinate and communicate quality activities with various company departments.
Perform and assist with the internal audit and supplier audit processes.
Assist in the preparation and support activities for all external audits.
Coordinate the distribution of Device Master Records (DMRs) for training purposes and assist with Engineering Change Notice (ECN) process as needed.
Assist with ensuring standard operating procedures (SOPs) are implemented, maintained, and continuously improved.
Coordinate and assist with the supplier approval and maintenance process.
Communicate with suppliers regarding acceptance or rejection of purchased product.
Collaborate with suppliers to improve quality and control measures to ensure all products meet customer specifications.
Review DHR documentation for completeness.
Develop and maintain product labelling as required.
Coordinate and document calibration activities.
Manage customer document requests and other quality related documentation.
Proactively identify opportunities to improve quality activities and communication.
Assist with maintaining compliance with all applicable domestic and international quality standards – internal, customer, certification body, regulatory.
Training new inspector, suppliers, and vendors on quality assurance procedures and protocols.
Provide back-up support for other roles, as necessary.
Support any other duties within the role or task assigned from time to time.
Additional Requirements:Knowledge of ISO 13485, FDA regulations, and EU MDR is an advantage.
Flexible attitude and ability to work in a rapidly changing manufacturing environment.
Strong attention to detail and excellent organisational skills.
Good analytical, problem-solving, and critical thinking abilities.
Strong leadership skills and effective communication.
Travel: Up to 15% (domestic/international)
Competitive salary package, including a 13th month salary.
Annual performance and salary review.
Excellent opportunities for career growth.
Enjoy a familial company atmosphere.
Group insurance plan and medical expense claims.#J-18808-Ljbffr