Operations Quality Analyst

Celestica; Kulai; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global technology firm in Johor is seeking an Operations Quality Analyst to manage quality phases including planning, corrective actions, and continuous improvement. You will lead quality activities, ensure adherence to KPIs, and develop quality control plans. Candidates must have a Bachelor's in Engineering and 3-8 years of relevant experience, particularly in PCBA for medical devices. The ideal candidate should possess strong analytical and communication skills and be capable of working independently.

Qualifications

• At least 3 - 8 years of working experience in the related field.
• Experience in PCBA and Box Build for Medical Devices (IQ,OQ,PQ process validation).
• Knowledge of ISO 13485 and/or ISO/IATF16949 is an advantage.

Responsibilities

• Manage quality excursions independently and take corrective actions.
• Develop the quality control plan for the respective area.
• Monitor and report on quality KPIs both internally and externally.

Skills

Analytical thinking

Excellent verbal and written communication skills

Ability to work independently

Education

Bachelor's Degree in Engineering (Electrical/Electronic or related)

Advanced/Higher Diploma

Tools

Minitab

Microsoft Excel

Job description

Req ID: 128084
Remote Position: No
Region: Asia
Country: Malaysia
State/Province: Johor
City: Senai

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 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 workmanshipstandards
• 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 jobs assignment from the superior and participate in the quality strategy deployment
• Continuous communication with customer to get better understanding on their requirements
• Transfer necessary Product Knowledge from customer to internal parties i.e. Trainers, ProcessEngineers, etc
• Lead in equipment validation protocol & reports (IQ, OQ and PQ) for new line setup & newproduct validation
• Lead quality activities to establish containment action and root‑cause in the event of ProductQuality Issues, Low Yields, Quality Reject, Product failures, etc

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 - 8 years of working experience in the related field is required for this position
• Preferably Senior Executives specializing in Quality Engineering
• PCBA experience and ISO 13485 knowledge 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 customer
• 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 willing to work in 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.

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.

COMPANY OVERVIEW

Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer‑centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full‑scale production and after‑market services for products from advanced medical devices, to highly engineered aviation systems, to next‑generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.