Operations Quality Specialist (PCBA & Medical Device)

Celestica; Johor Bahru; On-site; MYR 70,000 - 100,000; Full time

Job summary

A multinational technology company in Johor Bahru is seeking an Operations Quality Analyst to oversee quality management in processes related to medical devices. This role involves collaborating with teams, developing quality plans, and ensuring adherence to quality standards. Ideal candidates have a relevant engineering degree and 3-8 years of experience in quality engineering, particularly in PCBA and Box build processes.

Qualifications

• Candidate must possess at least a Bachelor's Degree or equivalent in Engineering.
• 3 - 8 years of working experience in Quality Engineering is required.
• Required experience in PCBA and Box Build for Medical Devices.

Responsibilities

• Manage quality excursions and take effective actions.
• Oversee product quality from NPI to mass production.
• Develop and maintain the quality control plan.
• Monitor and report quality KPIs.

Skills

Quality Management

Analytical Thinking

Communication Skills

PCBA Knowledge

Education

Bachelor's Degree in Engineering (Electrical/Electronic, Industrial, Mechanical, Mechatronic)

Tools

Minitab

Microsoft Excel

Job description

Summary

The Operations Quality Analyst is responsible for managing the three key phases of Quality Management—Quality Planning/Prevention, Corrective Action, and Continuous Improvement. This role collaborates with teams to achieve all quality KPIs and ensure adherence to quality standards.

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 the respective area (material/process/product)
• Monitor and report quality KPI for internal (factory) and external (customer)
• Drive continuous improvement to benefit the customer, CLS and supplier
• Develop and maintain internal quality system, procedures, work instructions and workmanship standards
• 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)
• Coach junior quality staff to improve their quality knowledge
• Accomplish the job assignment from the superior and participate in the quality strategy deployment
• Continuous communication with customer to get a better understanding of their requirements
• 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 in the event of Product Quality Issues, Low Yields, Quality Reject, Product failures, etc

Knowledge/Skills/Competencies

• Candidate must possess at least a 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 - 8 years of working experience in the related field is required for this position
• Preferably Senior Executives specialising in Quality Engineering
• PCBA experience and ISO 13485 knowledge are preferable
• Excellent Verbal and written communication skills
• Able to work independently
• Required: Experience in PCBA and Box Build for Medical Devices (IQ, OQ ,PQ process validation).

Preference

• Has experience, good analytical thinking and a systematic approach in managing in-process quality
• Tactful in handling customers
• Having a mindset of looking towards process prevention instead of correction
• Experience in PCBA and/or Box Build process would be an added advantage
• Hands-on involvement in both execution and review of Production Part Approval Process (PPAP) and/or validation activities throughout the manufacturing process for medical devices
• Experience in generating validation protocols for medical devices, as well as good knowledge of ISO13845 and/or ISO/IATF16949, would be an added advantage
• Has competency in 8D, SPC, FMEA, and Control Plan. Knowledge of Minitab or advanced Microsoft Excel would be an added advantage
• Good interpersonal skills
• Applicants are willing to work in the Senai, Johor area.