Quality Engineer

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

They will establish and manage Quality Assurance and Regulatory Compliance Systems to ensure compliance with Internal Corporate quality policies and procedures and external Regulatory and Industry standards requirement (ISO 9001, ISO 13485, Medical Device regulation in target countries such as US, Europe, China, Japan, and etc.). This includes developing and implementing business objectives, strategies, programs, tools, and processes to assure and improve quality and efficiency as well as to optimize customer satisfaction.

**Principle Duties/Responsibilities**:

- Establish, review, and streamline the QMS to assess continued suitability and effectiveness, including writing procedures and ensuring successful implementation.
- Coordinate audit or inspection by internal auditor, regulator, customer, or certifier.
- Manage periodic management review.
- Draft and review supplier contractual agreement.
- Responsible for CAPA workflow and ensure proper root cause analysis is done and updated timely.
- Implement key strategic programs or global procedure from corporate or business team for implementation at local site.
- Integrate quality management principles and methodologies into all critical business and decision-making practices.
- Involved in change management to provide input as voice of customer.
- Monitor quality metrics and perform trend analysis to identify improvement opportunities.
- Establish quality requirements and ensure suppliers, partners and contractors comply with them.

**Qualifications**:

- Bachelor's Degree, Master's Degree or equivalent education in any field.
- 2+ years’ of relevant experience in software release in a medical device manufacturing environment.
- Robust knowledge in Quality System Standards (ISO 13485, ISO 9001).
- Knowledge in Medical Devices regulation in EU/USA/China/Japan preferred.
- Proficiency in process validation and CSV desired.
- Proficiency in process analysis, problem solving and improvement using quality concepts/tools such as 8D, Lean, 5S, 6 sigma, root cause and/or statistical analysis.
- Proficient in audit, training, and documentation of quality management activities.
- Strong interpersonal skills with demonstrated ability to communicate and maintain effective working relationships across functions and levels both internally and externally.
- Strong documentation skills.
- Self-motivated and able to work independently.

As a federal contractor and healthcare company committed to protecting the health and safety of our employees, contractors, customers and communities, employees in the U.S., Puerto Rico, and Canada are required to be fully vaccinated against COVID-19, unless an approved exemption has been granted for a medical reason, sincerely held religious belief, or an employee is otherwise exempt under applicable law. Please see job postings for additional information.

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.

For more information about equal employment opportunity protections, please see all of our notices for EEO below.

**Option to Work Remote**:
**Travel Required**:
**Shift**: Day

**Duration**: No End Date

**Job Function**: Quality/Regulatory