Engineer, Quality
Location: Pasir Gudang, Malaysia
Job Summary:
The Quality Engineer is responsible for providing technical input for quality engineering throughout the product manufacturing process. This position handles multiple projects through manufacturing of finished devices. The incumbent provides a key role to ensure product meets defined production quality standards. The incumbent also supports facility activities including process validations and inspection and test activities.
Duties & Responsibilities:
- Assist Quality Manager on the quality assurance and product quality
- Supports product manufacturing through the application of quality engineering tools
- Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) and other applicable international standards and regulations
- Leads and participates in problem solving activities related to manufacture and inspection and test, including 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
- Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
- Develops and manages programs that monitor, predict, or regulate manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack
- In conjunction with the QA management, ensures robust application of the quality system by supporting the quality compliance process including the generation of data for NCR, RI and in process inspections.
- Any reasonable task assigned by manager, as applicable
- Works with the quality manager to report effectiveness of the quality management system to Masimo’s management representative.
Minimum & Preferred Qualifications and Experience:
Minimum Qualifications:
- Five to seven years of experience in quality engineering including practical experience in a device manufacturing environment
- Direct experience with ISO 13485
- Root Cause Investigation, failure analysis, root cause verification and developing robust corrective and preventive actions
- 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
- Experience in evaluating products to Product quality Standards
- Technical knowledge experience in electronic manufacturing
Education:
B.S. in Science or Engineering is required. M.S. in Science or Engineering, or an MBA, is preferred.
Physical requirements/Work Environment
This position works in office, laboratory and manufacturing environments. It requires frequent sitting, standing and walking. He or she needs to be able to recognize and differentiate color. He or she must also be able to lift up to 50 pounds. Daily use of computer 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
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