Job Description

JOB DESCRIPTION:MAIN PURPOSE OF ROLESummarize the main purpose of the role.Working under general supervision, is accountable for proper identification and analyses of quality issues with appropriate corrective action and timely resolution. Also ensures that Qualifications Tests are conducted according to plan, that failures are analyzed and corrective actions are suggested and implemented. Provides technical and analytical support to Production to define and resolve problems. Work assignments are performed in accordance with Company policy and procedures, regulatory agencies standards and requirements and within specified parameters. Independently conceives, plans and conducts original technical projects. Full responsibility for assignment may be given in a particular area. Work is reviewed for soundness of judgment and overall adequacy and accuracy. Contributions affect team/organization results. Performs assignment of moderate complexity, developing solutions to a variety of problems, generally requiring some design work, Applies existing work methods and principles to different known situations. Frequent use of independent judgment. Internal: Has informational contact and Interfaces with various production, engineering and quality personnel for validation, verification and coordination purposes related to design and development. Interfaces with Project Managers on project status, test procedures, product reliability issues and test results; R&D Engineering Reporting on failures analysis, Product and Production Engineers. Provides technical guidance and support to other engineers and/or technicians, mentor less experienced engineers. External: Interacts with various vendors relating to delivery, installation, test and validation. Working under general supervision, validates and evaluates data, analyzes cause of failures, suggests remedies and writes up results. Work requires application of theoretical principles and creative/analytical techniques. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Remains abreast of and consults on technical advancements and industry specifications/standards. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Conduct audit quality systems for deficiency identification and correction. Justification (Please provide Justification if this is a change of previous JD)MAIN RESPONSIBILITIES1. Support day to day production/engineering by resolving process and material related quality issues2. Leading and perform root cause analysis on non-conformance such as Customer Complaint, Nonconforming Material Report (NCMR), Corrective and Preventive Action (CAPA), final QC rejects etc.3. Provide training to QC personnel, as applicable, with regards to acceptance criteria for manufactured product.4. Drive for continuous improvement activities (Core team, Six Sigma Green Belt (SSGB), etc.).5. Support NPI team for qualification and validation/verification activities.6. Assist in development of quality system processes, e.g. records management and document control, control of electronic data etc.7. Conduct periodic line audits/ gemba walk to assess for production controls 8. Provide trending analysis on performance metrics9. Support third parties or regulatory inspection readiness and preparation activitiesOther Duties: Number and list any important but non-essential and/or infrequent duties performed.MAIN RESPONSIBILITIES1. Assist other Quality Engineering personnel whenever necessary.2. Remains current on development in fields (s) of expertise, regulatory requirements as well as industry trends. Remains abreast of and consults on technical advancements.3. Resolves and/or facilitates the resolution of problems including identifying causes to prevent re-occurrence.4. Performs related functions and responsibilities on occasions, as assigned. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and requirements, which may change from time to time based on business needs. The qualifications requirement may be changed from time to time based on business needs.QUALIFICATIONSEducation Education LevelMajor/Field of Study or Education Level Diploma or Degree in a relevant field with relevant experience. Those without the academic qualifications but with relevant experience or with relevant academic qualifications but without relevant experience will also be considered.Experience/Background Experience Experience Details- N/AThe base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: CRM Cardiac Rhythm ManagementLOCATION: Malaysia
Penang : Plot 102, Lebuhraya Kampong Jawa Bayan Lepas Industrial Zone 11900ADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 5 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable

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