Senior Quality Engineer

Overview Senior Quality Engineer — Posting Date : 26 Sep 2025 | Close Date : 25 Dec 2025

Client Background : Medical device manufacturing company

Location : Batu Kawan, Penang

Tenure : Permanent

Headcount : 1

Responsibilities

Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.

Read and interpret technical drawings, procedures, and protocols.

Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.

Identify manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.

Participates in Customer Complaints investigation for areas under their control.

Document investigation findings in analysis report on GCS2.

Become a trainer for the Software related with complaints handling process (GCS2), as required.

Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.

Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.

Is viewed as a leader in the areas of QSR and ISO / MDD standards within one’s own group, promoting awareness of best industry practices and making appropriate decisions daily using the Quality Engineering Manager / Site QA Director as the final arbitrator on critical quality decisions.

Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.

Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.

Champions continuous improvement and innovation from a quality perspective within the department—from vendor selection / approval through to customer awareness / satisfaction.

Gives technical guidance to Quality Engineers, Associate Quality Engineers, technicians and inspection staff.

Works with EHS to identify significant environmental impacts of operations and to establish goals and targets around environmental impacts.

Deals with suppliers, other engineering disciplines within and outside of Site and customers as needed.

Is familiar with the internal auditing process.

Qualifications

Minimum Degree in Engineering field.

At least 9 years of working experience in Operations Quality. Prior experience in the medical device industry is preferred.

Resolves issues using standard problem-solving tools and a strong understanding of quality operations fundamentals, including product risk assessment and data analysis to identify root causes and drive solutions. Communicates findings clearly and effectively. Cross-functional management experience is a plus.

Experience in product transfer will be an added advantage.

Work Location Penang

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