Responsibilities:
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 the Final 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.
12) On-site supplier product inspection if required.
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.
18) Control nonconforming product retention.
Pre-requisites:
1) Willing to perform rotating shift
2) Good attitude
3) Candidate must be hardworking, willing to learn and responsible.
4) Applicant must be willing to work in shift.
Located in the heart of ASEAN, Malaysia, Ortho Solutions is a contract manufacturer of orthopaedic implantable medical devices and instruments.