Quality Control Inspector

Ortho Solutions Sdn. Bhd.; Seberang Perai; On-site; MYR 22,000 - 31,000; Full time

Job summary

Ortho Solutions Sdn. Bhd. in Penang, Malaysia, is seeking a Quality Control Inspector to perform dimensional, visual and functional inspections during Final Quality Release.

You will use calibrated measuring tools and ensure data accuracy while maintaining ISO compliant records. The role requires reading engineering drawings, strong attention to detail, and the ability to work in shifts. You will be responsible for nonconformity reporting, calibration upkeep, and collaboration with manufacturing

Qualifications

• Able to read and interpret engineering drawings.
• Strong attention to detail and manual dexterity.
• Effective verbal and written communication.

Responsibilities

• Perform Dimensional, Visual & Functional Inspection during Final Quality Release using specified measuring devices and procedures.
• Carry out inspections per the shipping plan to ensure on-time delivery.
• Prepare Inspection Reports or First Article Reports as required by customers.
• Prepare QC COC and verify reports and checklists for special process requirements.
• Report nonconformities and initiate Nonconformity Material Reports.
• Ensure nonconforming products are segregated from good products.
• Conduct in-process inspections per procedure and communicate results for manufacturing adjustments.
• Participate in product quality complaint investigations.
• Perform incoming inspection on raw materials and receiving inspection of purchased parts according to specifications.
• Inspect according to inspection procedure and ensure calibration and maintenance of equipment.

Skills

Reading drawings

Attention to detail

Manual dexterity

Verbal and written communication

Tools

Calliper

Micrometre

Job description

1) Performing the Dimensional, Visual & Functional Inspection during the Final Quality Release process for products according to the specifications with the appropriate measuring device from the specify procedure with specified sampling plan.

2) To carry out the inspection activities as per shipping plan on the lot arrangement from time to time in order to achieve on time delivery to customer.

3) Prepare the Inspection Report or First Article Report as per customer requirement and ensure all data recorded are accurate and correct.

4) Prepare QC COC at theFinal Quality release activities and conduct verification activities on all COC and necessary report for all special process requirements to ensure complying the customer requirements/Internal specification accordingly and verified with checklist provided.

5) Report on process or product nonconformity that can or may cause customer dissatisfaction, and / or produce of unsafe or ineffective device.

6) Raise Nonconformity material Report for any nonconformity product that detected during the inspection activities and discuss the inspection result with the related team.

7) Ensure the the nonconformity product will segregate from good product as a practice from time to time.

8) Conduct In-process Inspection that is requested by manufacturing due to limitation on measuring equipment. The Inspector shall inspect as per Inspection Procedure and communicating on the result that required adjustments to manufacturing team.

9) Participate in product quality complaint investigation.

10) Perform in-coming inspection on raw materials from suppliers as per specifications.

11)Inspects incoming purchased parts/Receiving Inspection by confirming specifications included visual Inspection according to Inspection Procedure.

13) To ensure all Inspection activities is comply with Intech Penang's QMS and ISO 13485 requirements.

14) Update and maintain inspection documents, forms, logs, conformance certificates and other records.

15) Monitor the use of equipment to ensure it is safe and well-maintained and discard any that doesn’t meet requirements to superior standard.

16) Keeps measurement equipment operating by following available work Instruction and calibration requirements, report to superior for any out of calibration or gage that over the frequency limit that planned.

17) Maintain and protect measurement and testing equipment as per operating requirement.

Pre-requisites:

Able to read and interpret engineering drawings.

Good attitude and able to work independently.

Candidate must be hardworking, willing to learn and responsible.

Able to use QC measuring equipment. Eg: Calliper, Micrometre,

Applicant must be willing to work in shift.

Able to work overtime if necessary.

Strong attention to detail and manual dexterity for handling small/sensitive parts.

Effective communication skills, both verbal and written

Self-awareness, integrity, authenticity, and a growth mindset

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Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?
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• How many years' experience do you have as a Quality Control Inspector?
• Which of the following types of qualifications do you have?

Pharmaceuticals, Biotechnology & Medical Devices 101-1,000 employees

Ortho Solutions Sdn. Bhd., part of EXALTA, is a medical device contract manufacturer based in Penang, Malaysia, specializing in the precision manufacturing of orthopaedic implants and surgical instruments for the global medical device industry.

Our products are manufactured to meet demanding requirements for quality, precision, reliability, and traceability. Through our manufacturing capabilities and technical expertise, we support global medical device customers in bringing innovative orthopaedic products to patients around the world.

Ortho Solutions Sdn. Bhd., part of EXALTA, is a medical device contract manufacturer based in Penang, Malaysia, specializing in the precision manufacturing of orthopaedic implants and surgical instruments for the global medical device industry.

Our products are manufactured to meet demanding requirements for quality, precision, reliability, and traceability. Through our manufacturing capabilities and technical expertise, we support global medical device customers in bringing innovative orthopaedic products to patients around the world.

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What can I earn as a Quality Control Inspector