Quality Engineer/ Senior Quality Engineer

Intersurgical Medical Sdn Bhd; Simpang Ampat; On-site; MYR 60,000 - 90,000; Full time

Job summary

Intersurgical Medical Sdn Bhd in Penang, Malaysia, invites a Quality Engineer/Senior Quality Engineer to join our manufacturing quality team. You will oversee audits, CAPAs, DHRs and CAPA tracking to ensure products meet regulatory and customer requirements.

Candidates hold a Bachelor in Engineering or Science with at least 3 years in a manufacturing environment, preferably medical device. Strong knowledge of ISO13485, FDA/EU MDR is a plus; fluent English and Bahasa Malaysia are expected.

Qualifications

• Bachelor’s degree in engineering, science, or equivalent.
• Minimum 3 years in a manufacturing environment, preferably medical device manufacturing.
• Knowledge in ISO13485, FDA regulations, and EU MDR is an advantage.
• Technical experience in medical devices and Quality Management Systems.
• Auditing, inspections, and quality assurance experience.
• Detail-oriented, systematic, and able to work with minimal supervision.

Responsibilities

• Oversee and organize day-to-day quality staff activities for inspections and documentation.
• Supervise and coach team members; assign tasks to meet schedules and targets.
• Review DHR documentation for completeness and accuracy.
• Manage quality metrics: non-conformance, SCAR, customer complaints, CAPA.
• Drive CAPA process and root cause analysis; prepare investigation reports.
• Prepare monthly quality performance indices and coordinate quality activities with departments.
• Coordinate distribution of Device Master Records for training and assist with ECN processes.
• Assist with SOP implementation and continuous improvement.
• Perform internal and supplier audits; support external audits.
• Coordinate supplier approvals and maintain related documentation.
• Communicate with suppliers on acceptance/rejection and drive quality improvements.
• Identify opportunities to improve quality activities and cross-functional communication.
• Maintain compliance with domestic and international quality standards.

Skills

Quality assurance

Auditing

CAPA

Root cause analysis

Documentation

SOPs

Cross-functional collaboration

Problem solving

English language

Bahasa Malaysia

Education

Bachelor’s Degree in Engineering, Science or equivalent

Job description

Quality Engineer/ Senior Quality Engineer

Intersurgical is a global medical device manufacturer specializing in respiratory care products used by healthcare professionals worldwide. As part of the Intersurgical Group, we are committed to quality, innovation, and patient safety, providing trusted solutions for hospitals, emergency care, and homecare settings.

As we continue to expand our business operations, we are actively seeking passionate and driven individuals to join our growing team.

Qualifications & Experience:

Candidates must possess at least a Bachelor’s Degree in Engineering, Science or equivalent.

Minimum 3 years of work experience in manufacturing environment, preferably medical device manufcaturing.

Knowledge in ISO13485, FDA regulations, EU MDR is an advantage.

Technical experience within the areas of medical device and Quality Management Systems

Experience in auditing, inspections, and quality assurance.

Innovative, committed with good accountability.

Detail-oriented, systematic and able to work under minimum supervision.

Ability to see the big picture while focusing on the process and procedure necessary to produce deliverables. Attentive to details and able to multitask in an orderly and efficient manner.

Good interpersonal skills to collaborate effectively with cross-functional teams.

Problem solving skill is highly preferred.

Good command of both oral and written English and Bahasa Malaysia.

Key Responsibilities:

Oversee, plan, coordinate, and organize 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; prioritize and assign tasks to ensure that the team's resources are used effectively and that work schedules and targets are met.

Review DHR documentation for completeness and labelling for accuracy.

Manage quality matrices - Non-conformance (NCMR), Supplier Corrective Action Request (SCAR), Customer Complaint, Corrective and Prevention Action (CAPA).

Drive CAPA process and follow through root cause analysis and CA implementation. Prepare investigation report as required.

Compile monthly quality performance indices, report / trending, coordinate and communicate quality activities with various company departments.

Coordinate the distribution of Device Master Records (DMRs) for training purposes and assist with Engineering Change Notice (ECN) process when needed.

Assist with ensuring standard operating procedures (SOPs) are implemented, maintained, and continuously improved.

Perform and assist with the internal audit and supplier audit processes.

Assist with the preparation and support activities for all external audits.

Coordinate and assist with the approval and maintenance process for supplier.

Communicate with suppliers regarding acceptance or rejection of purchased product.

Work with supplier to improve quality and control required to assure all products are manufactured to meet customer specifications.

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 Quality roles, as necessary.

Support any other duties within the role or task assigned from time to time.