Quality Manager

BD (Tissuemed Ltd); Kulim; On-site; MYR 80,000 - 120,000; Full time

Job summary

A leading medical device company in Malaysia is seeking a Quality Assurance Manager to oversee QA activities in manufacturing. The ideal candidate will have 5-8 years of experience in production or quality assurance, a related engineering degree, and relevant certifications. Responsibilities include managing quality control functions, liaising with production teams, and leading quality improvement initiatives. Fluency in Bahasa Malaysia and English is essential.

Qualifications

• Minimum 5 – 8 years’ experience in production, quality assurance or manufacturing engineering.
• Experience with SPC, QC tools, DOE, ANOVA and Minitab.

Responsibilities

• Manage overall QA activities in manufacturing including supplier management and quality control.
• Liaise with production teams to ensure product quality.
• Lead quality improvement activities and resolve quality issues.

Skills

Fluent communication in Bahasa Malaysia

Fluent communication in English

Quality Engineering tools and techniques

Statistical analysis

Education

Bachelor’s Degree in Science/Engineering/Manufacturing

Certified Quality Auditor (ASQ CQA/RABQSA/IRCA/EOQ)

Lean Six Sigma Black Belt

Certified in CQA and CQM

Job description

Job Description Summary

Responsible for incoming and supplier management, in-process quality control, qualification, customer complaint and QA activities in manufacturing to ensure that the quality system is in compliance with the quality assurance policies of the company.

Plan, organize, coordinate and lead projects related to process, manufacturing and quality to support the requirements of the Quality Assurance System. Provide leadership in the analysis and resolution of manufacturing quality problems using specific techniques and tools. Evaluate the state of manufacturing processes to ensure adequate control and continuous improvement.

Essential Duties and Responsibilities

Responsible for overall management of QA Activities in manufacturing (incoming, supplier management, in-process and releasing, qualification, audit, customer complaint and etc). Liaise with production supervisors/officers/engineers/managers on matters relating to quality as to ensure that products are manufactured to requirements. Assure that all quality control functions are performed effectively to meet production schedule through planning and good communication. Lead a quality staff to ensure proper implementation and maintenance of a quality system in compliance with the Quality System Regulation, ISO 13485:2003, National and International Standards, product specifications and Corporate, Divisional and Internal policies and procedures. Perform continuous Quality Control evaluation and trend analysis on product quality issues, resolve quality problems and initiate corrective action with other departments as required. Lead and motivate subordinates to achieve the highest level of proficiency. Provide leadership and training on statistics and analytical tools to facilitate employee involvement in problem‑solving or quality improvement activities. Participate or lead quality improvement activities pertaining to advising quality trend and customer complaints.

Education & Qualification

• Bachelor’s Degree in Science/Engineering/Manufacturing related field
• Certified in Quality Auditor (ASQ CQA/RABQSA/IRCA/EOQ). Either of the listed will satisfy the requirement.
• Certified in Lean Six Sigma Black Belt, CQA and CQM

Experience

• Must be able to communicate fluently (written and oral) in Bahasa Malaysia and English.
• Minimum 5 – 8 years’ experience in a manufacturing environment on Production, Quality Assurance or Manufacturing Engineering.
• Exposed to Quality Engineering tools and techniques, e.g. SPC, QC tools DOE, ANOVA and Minitab.

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

MY3 Normal 8a-4.45p Group 26 (Malaysia)