Job Description

Essential Duties and Responsibilities:

Assist with development of test plans, test cases, and test scripts on multiple projects simultaneously.

Independently define and enforce the strategies for integration, system, and regression testing and test environment during V&V.

Create, track, and complete regulated documentation for SW V&V process such as change orders, test plans, reports, and relevant attachments.

Review and update documentation in response to feedback from stakeholders.

Participate in design review and change control meetings.

Work with developers or vendors to perform root-cause analysis and preliminary problem diagnosis.

Identify defects and track them from discovery to resolution.

Conduct manual and automated testing of software.

Quickly learn all essential aspects of fast paced manufacturing testing system.

Basic SQL Knowledge for (SELECTS, JOINS, and execution)

Other duties as assigned

Required Qualifications:

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 5 years related experience or Master's degree and 3 years equivalent industry experience.

Preferred Qualifications:

Experience with data processing and reporting systems.

Experience with medical manufacturing systems and processes.

Proficient in all software testing phases.

Understand medical device software development process and participate in efforts to improve SDLC processes.

Extensive experience working as a quality engineer for product manufacturing software or developing or validating software for product manufacturing equipment.

Quick learner and adjust easily to a dynamic, fast paced environment

Intermediate Python programming.

SQL query modification and execution.

User Interface testing experience.

Familiar with JIRA, Valgenesis, and/or Smartsheet.

Experience in software for operating manufacturing or testing equipment.

Experience in FDA regulated software development.

Experience in using documentation, task, defect, requirement, and test case management systems such as Oracle Agile PLM, Jira, ValGenesis, or similar.

Expertise in 21 CFR Part 11 compliant systems.

Familiarity with 21 CFR 820 a plus.

Experience with ISA 95 model a strong plus.

Travel Required:

Up to 25%

Functional Description

: Technical Individual Contributor

Designs, develops, troubleshoots, and debugs software test cases and strategies based off requirements. Gives feedback on testing and requirements as needed.

Functional/Business Knowledge:

Possesses knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.

Scope:

Demonstrates technical expertise, collaboration with others, and independent thought. Anticipates potential complex problems requiring an in-depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.

Judgement:

Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.

Determines methods and procedures on new assignments.

Job Type: Contract
Contract length: 12 months

Pay: RM10,000.00 - RM12,000.00 per month

Application Question(s):

What is your current/last drawn salary? What is your expected salary?
Work Location: In person