Job Responsibilities
Performs tasks such as, but not limited to, the following:
- Lead the team to handle all quality excursions independently, and take effective actions on time.
- Oversee the product & material quality from NPI to mass production.
- Develop the quality control plan for respective area (material/process/product).
- Monitor and report quality KPI for internal (factory) and external (customer).
- Drive continuous improvement to benefit customer, CLS and supplier.
- Develop and maintain internal quality system, procedures, work instructions and workmanship standards in alignment with ISO 13485 and FDA regulations.
- Follow up the EC (Engineering Change), SPCN (Supplier Process Change Notification) to ensure the implementation of changes is timely and accurate (initiated both externally and internally).
- Continuous communication with customer to get better understanding on their requirements while remaining tactful in handling customer relations.
- Transfer necessary Product Knowledge from customer to internal parties i.e., Trainers, Process Engineers, etc.
- Lead in equipment validation protocol & reports (IQ, OQ and PQ) for new line setup & new product validation.
- Lead quality activities to establish containment action and root-cause (managing CAPA/NCR processes) in the event of Product Quality Issues, Low Yields, Quality Reject, Product failures, etc.
- Coach junior quality staff to improve their quality knowledge.
- Accomplish the jobs assignment from the superior and participate in the quality strategy deployment.
Job Requirements
- Candidate must possess at least Diploma, Advanced/Higher/Graduate Diploma, Bachelor's Degree, Professional Degree, Engineering (Electrical/Electronic), Engineering (Industrial), Engineering (Mechanical), Engineering (Others), Engineering (Mechatronic/Electromechanical) or equivalent.
- At least 3 - 5 years of working experience in the related field is required for this position. Preferably Senior Executives specializing in Quality Engineering.
Required:
- Experience in PCBA and Box Build for Medical Devices (IQ, OQ, PQ process and utility validation including Test Method Validation).
- Deep knowledge of ISO13845, with a strong understanding of ISO 14971, QMSR, FDA 21 CFR Part 820 highly preferred. Knowledge of ISO/IATF16949 would be an added advantage.
- Hands-on involvement in both execution and review Production Part Approval Process (PPAP) and/or validation activities throughout manufacturing process for medical devices as well as experience on generating validation protocols for medical devices.
- Has the competency on 8D, SPC, FMEA, Control Plan and Product Quality Plan. Knowledge on Minitab or advanced Microsoft excel would be an added advantage.
- Having mindset of looking towards process prevention instead of correction, along with good analytical thinking and systematic approach in managing in process quality.
- Excellent Verbal and written communication skills and good interpersonal skill.
- Able to work independently.
- Applicants willing to work at the Senai, Johor area.
