Operations Quality Analyst - Health Tech (Medical Devices)

Detailed Description

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.

Knowledge/Skills/Competencies

• 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.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.