Quality Engineer

Quality engineers at manufacturing takes care of product quality and quality management system compliance to ensure best in class customer experience, and act as voice of customers.

**Principle Duties/Responsibilities**:

- Make sure desired quality of products are maintained and delivered to customers.
- Develop and implement programs and processes to ensure that the products are safe, and regulatory requirements are met, and exceed customer experience.
- Ensure compliance with Internal Corporate quality policies and procedures and to external regulations and standards (FDA, ISO 9001, ISO 13485, CSA, etc.).
- Consistently monitor on product quality performance and work with cross functional team to drive for improvement.
- Lead improvement initiatives to improve DEFOA and AFR.
- Write and revise QMS processes and procedures and related manufacturing documents.
- Perform quality assessments and work with cross-functional teams to ensure appropriate changes, investigations and corrective/preventive actions are documented.
- Execute key strategic programs initiated by corporate or businesses.
- Monitor and measure the quality metrics and initiate improvement program to improve customer experience.
- Clearly understand customer needs and provide products and services that meet those needs.
- Comply with relevant regulatory requirements in terms of technical regulations and environmental requirements.
- The quality engineer will ensure the organization has the processes, tools, skills and understanding to execute to expectations in the following areas:
1. Quality Information: Provides the following information to management team for
- Quality summary month (Defect on Arrival and Annual Failure Rate)
- Product reliability improvement goals and progress.
- Manufacturing/Supplier/Contract Manufacturer quality performance (Yield, OQA rate & etc.)

2. QMS Conformability: Establish and continuously improve the effectiveness of the Quality Management System, our processes, products and services. Facilitate internal and external quality audits.

Other Responsibilities: Manages the development and implementation of business objectives, strategies, processes, tools, and systems to improve quality and productivity, optimize customer satisfaction.

**Qualifications**:

- Demonstrated ability to lead and maintain effective working relationships across functions and organizations.
- Demonstrated effectiveness with interpersonal skills and the ability to interface with cross functional team (internally and external).
- Ability to contribute at the global / strategic business level initiatives.
- Ability to perform data analysis, root cause analysis, troubleshooting, problem solving, statistical analysis and related skills.
- Experience in Quality Assurance of in Vitro Diagnostic, Medical Devices and/or pharmaceuticals is added advantage.
- Adequate knowledge in Quality System Standards (ISO13485, FDA CFR 21 Part 820) and IVD/Medical Devices legislation in EU and USA is added advantage.
- Fluency in English (verbal and written).
- Strong problem solving skills
- Strong communication skills
- Strong documentation skills
- Self-motivated and able to work independently

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

**Travel Required**: Occasional

**Schedule**: Schedule:Full time

**Shift**: Day

**Duration**: 0-3 Months

**Job Function**: Quality/Regulatory