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QC Engineer
JLL Malaysia Sdn. Bhd.Simpang Empat, Perak, Malaysia16 jam yang lalu
Penerangan pekerjaanReview procedures and records periodically with related parties to maintain effectiveness of the implementation. Revise applicable procedures or records when necessary. Monitor inspection process & flow (including yield, takt time, inspection progress, shipment delay, rework etc), collect relevant data, analyze data, define improvement actions & check effectiveness of actions Report to related parties on improvement actions taken and the effectiveness Create & maintain limit samples and conduct training to inspectors based on the samples Update & maintain return product list after receiving new return notifications and after each processing (verification, rework, NG, shipped etc). Update monthly yield whenever re-shipped or NG. Arrange return product rework & inspection (liaise with MFG, QC and Logistics) for re-shipment Set-up workstations as required and propose layout to the management Study & monitor takt time and advise the headcount needs For new products, conduct training to the initial team members and prepare training plan or checklist, including qualification method, to be used for future training Verify judgment when required (OK / NG) by the QC team Organize or attend any meetings related Support inspection when required Issue NCR and evaluate non-conformances. Determine the need for investigation for each of the NCR recorded. Main PIC for CAPA (issuance, reporting & follow-up) for internal issues (depending on the risk to customer) Lead investigations with FRT team members and follow up on root cause investigations, corrective actions implementation, effectiveness of corrective actions etc until closure. Lead FRT & NC product disposal meetings. Lead discussions with team related to preventive actions, Yokoten, Lessons Learned etc Coordinate any quality improvement plan when necessary Report to related parties, including to the management when needed Conduct risk assessment for QC processes Determine appropriate actions to reduce risk to acceptable level or to meet the requirements Provide input based on non-conformities found in the QC processes Propose changes to the QC processes when needed, following the defined procedures. Only implement when the changes are approved. Monitor any risks or impact to the product quality after change implementation, report to related parties and take necessary action. Other tasks which are related to the job scope Support audits when necessary Regular working hour from 8 am to 5 pm Monday - Friday (option to apply for flexi hour) Attractive salary offered based on experience & skills Reimbursement on mileage, toll & business trip Free & wide parking area Meal, attendance & phone allowances Corporate insurance GHS & GPA Medical benefits which include GP, dental & optical Other miscellaneous allowance Cell phone reimbursement Flexible schedule Free parking Health insurance Maternity leave Meal allowance Opportunities for promotion Professional development Simpang Ampat : Reliably commute or planning to relocate before starting work (Required) How much notice are you required to give your current employer? Manufacturing : 2 years (Required) Medical device industry : 2 years (Preferred) Quality control : 2 years (Required) Auditing : 1 year (Preferred)
QC Engineer - OEM Division
Requirement :
- Bachelor's Degree in Engineering or any related field.
- Minimum 3 years' experience in the manufacturing industry.
- At least 2 years' experience in quality or process-related functions is an advantage.
- Proficient in FMEA, risk management, control plans, and preparation of work instructions.
- Skilled in problem-solving and data analysis using tools such as the 7QC tools, Non-Conformance Reports, and Why-Why Analysis.
- Experienced in preparing and implementing SOPs, including document and record control, in line with ISO requirements.
- Knowledge of ISO 13485 and other relevant regulated medical device standards is an advantage.
- Strong analytical and decision-making skills with the ability to identify and resolve issues effectively.
Scope of Duties :
Process, Yield Monitoring & Improvement
Establish all required work procedures and records etc for the OEM project with related team members following ISO 13485 as well as FDA and customer requirements.
2. NC & CAPA
3. Risk Management for QC processes
4. 4M Change Request
5. Others
Benefits include :
Job Types : Full-time, Permanent
Pay : RM3, RM5,000.00 per month
Benefits :
Ability to commute / relocate :
Application Question(s) :
Experience :
Work Location : In person
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Engineer • Simpang Empat, Perak, Malaysia
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