Sr. Engineer, Quality

Location: Pasir Gudang, Malaysia

Job Summary:

The Sr Engineer, Quality plays a critical role in ensuring product quality, regulatory compliance, and continuous improvement across manufacturing and engineering processes. This position will handle multiple projects from product inception, development, through manufacture and customer use. The incumbent provides a key role to ensure products meet defined quality and safety standards, and worldwide regulatory requirements. The Senior Quality Engineer acts as a key liaison between design, production, suppliers, and customers to uphold quality standards and ensure customer satisfaction. 

Duties & Responsibilities:
• Assist Quality Manager on the quality assurance and product quality
•Supports new product development and product manufacturing through the application of quality engineering tools
•Assure conformance of systems and processes during the development, manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations
•Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
•Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
•Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
•Develops and manages programs that monitor, predict, or regulate research and development, manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack.
•Identify and document any discrepancies, missing information, or deviations found during the review process and initiate corrective actions or nonconformance reports as necessary. Collaborate with manufacturing, quality, and engineering teams to resolve DHR-related issues and ensure timely closure of open items.
•In conjunction with the QA management, ensures robust application of the quality system by supporting the management review process, including the generation of data for CAPA, NCR, in RI and in process inspections, internal and external, audits and customer feedback activities
•Participates with regulatory compliance group in leading and developing Risk Analysis according to ISO 14971/ IEC 60601-1, 3rd Edition
•Interfaces with various product certification agencies such as UL, CSA, and external laboratories to obtain product safety certifications to applicable product safety standards (i.e., IEC 60601-1, 3rd Edition, ISO 80601-2-61, etc.)
•Support internal and external audits by providing complete and readily retrievable DHRs and addressing any audit findings related to recordkeeping or product release.
•Participate in continuous improvement efforts to streamline DHR review processes and enhance documentation practices for compliance and efficiency.
•Any reasonable task assigned by Superior from time to time
 

Minimum & Preferred Qualifications and Experience: 

Minimum Qualifications:
•1–3 years of experience in manufacturing, quality assurance, or document control. Experience with Good Manufacturing Practices (GMP) and/or FDA 21 CFR Part 820 compliance is highly preferred.
•Root Cause Investigation, failure analysis, root cause verification and developing robust corrective and preventive actions
•Working knowledge of Device History Records (DHR), Device Master Records (DMR), and quality system documentation.
•Strong attention to detail and ability to spot inconsistencies or missing documentation
•Direct experience in quality system audits
•Ability to occasionally travel internationally
•Proficiency with Microsoft Office applications
•Strong communication, documentation, problem solving and leadership/management skills
•Strong Project Management experience
•Must be an independent worker, who is flexible and adaptable
 

Preferred Qualifications:
•Microsoft office knowledge
•Solid understanding of Good Manufacturing Practices (GMP) and FDA regulations (e.g., 21 CFR Part 820).
•Proficiency with document management systems and tools (e.g., Microsoft Office, ERP/QMS software).
•Experience in evaluating products to Product quality Standards
•Technical knowledge experience in electronic manufacturing
 

Education:
Associate’s or Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or a related field.

Physical requirements/Work Environment
 

This position works in offices, laboratory and manufacturing environments. It requires frequent sitting, standing and walking. He or she needs to be able to recognize and differentiate colors. He or she must also be able to lift up to 50 pounds. Daily use of computers and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, performing audits and laboratory testing. Some international travel is required, so a valid international travel passport is required. Also, some local is necessary, so the ability to operate a motor vehicle and maintain a valid driver license is required.
 

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with reals or perceived disabilities to perform the essential functions of the job described

Job Summary: We are seeking a highly skilled and motivated Quality System Engineer to join our team. The ideal candidate will be responsible for developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and regulations. The Quality System Engineer will play a key role in enhancing product quality, improving processes, and driving continuous improvement initiatives.