Quality Engineer

Job Description

The Quality Engineer role is dedicated to ensuring the highest quality experiences for our patients and customers. This position is responsible for driving and supporting quality assurance activities related to manufacturing, including Change control, NCRs and CAPAs, Audit support, and assisting in Product Complaints technical investigations for the relevant product platforms.

Job responsibilities include:

• Drive product quality investigations resulting from complaints and support root cause investigations concerning product and manufacturing issues.

• Review and align CAPAs (Corrective Action / Preventive Action) according to corporate procedures and guidelines across the division.

• Support 3rd party audit of site through audit prep and participating in the front/back room

• Understand complex processes, problems, and quality/compliance issues, and describe them in a clear and concise manner suitable for audit and inspection settings.

• Collaborate closely with other quality functions and quality engineers within the team.

• Support Manufacturing in ensuring compliance when making minor design changes and updates to our product portfolio.

• Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.

• Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.

• Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.

• Act as a subject matter expert in routine quality assurance and scientific matters as applicable.

• Develop and drive key strategic quality assurance and manufacturing initiatives throughout the organization.

• Collaborate with other quality partners to identify required quality assurance skills and competencies to implement strategic visions or plans.

• Involve in quality systems initiatives as a primary or additional assignment, potentially impacting business improvement, quality systems, and lifecycle management.

• Lead/drive root cause investigations for multiple issues including complaints, NCRs, OOS, etc.

• Be responsible for the implementation of supplier corrective actions and ensuring supplier changes are implemented in a compliant manner.

• Perform other duties as assigned.

Qualifications

• Bachelor’s or Master’s Degree in biology, chemistry, biotechnology, engineering, or a related field or equivalent experience

• Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQE, CQA, etc. preferred

• 8+ years relevant experience for entry to this level

• 5 years of experience in a medical device industry

• Requires in-depth technical knowledge within the area described in duties and responsibilities.

• Strong organizational and analytical skills with focus on finding effective and efficient solutions in compliance with the regulations.

• An effective communicator at all levels, both internally and externally

• Team player with the ability to make independent decisions within the framework and guidelines of the organization.

• Strong technical writing, reviewing, and editing skills.

• Familiar with medical device regulation, such as ISO13485 and 21CFR820

The US pay range for this full-time position is $119,784.00 - $187,163.00/yr, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Additional details are available at: https://careers.agilent.com/locations/americas/united-states/

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.

Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Option to Work RemoteYes

Travel RequiredOccasional

ShiftDay

DurationNo End Date

Job FunctionQuality/Regulatory