About the Company
Agilent Technologies is a global leader in life sciences, diagnostics, and applied chemical markets. With more than 16,000 employees serving customers in 110 countries, we provide laboratories worldwide with instruments, services, consumables, applications, and expertise, enabling customers to gain the insights they seek. Our commitment to innovation and quality drives everything we do, fostering an environment where breakthroughs happen and careers thrive. Join a company dedicated to improving the quality of life around the globe.
Job Description
Join Agilent Technologies as a Laboratory Quality Coordinator with a strong regulatory focus. In this critical role, you will be instrumental in ensuring our laboratory operations consistently meet rigorous quality standards and regulatory requirements. You will support the development, implementation, and maintenance of our Quality Management System (QMS), ensuring compliance with relevant industry regulations such as ISO 13485, FDA 21 CFR Part 820, and other applicable guidelines. This position requires a keen eye for detail, a proactive approach to quality improvement, and excellent communication skills to collaborate effectively across departments. You will work within a dynamic team, contributing directly to the integrity and reliability of our lab processes and products.
Key Responsibilities
- Coordinate and support internal and external audits (e.g., ISO, FDA), facilitating auditor requests and ensuring timely follow-up on findings.
- Assist in the development, revision, and implementation of Standard Operating Procedures (SOPs), work instructions, and other quality documentation.
- Facilitate training on quality systems and regulatory requirements for laboratory personnel, ensuring understanding and adherence.
- Monitor and track quality metrics, non-conformances, CAPAs (Corrective and Preventive Actions), and deviations, driving resolution where necessary.
- Support the investigation of quality issues, root cause analysis, and ensure timely resolution and comprehensive documentation.
- Maintain accurate and up-to-date quality records and documentation, ensuring audit-readiness and data integrity.
- Collaborate with R&D, manufacturing, and operations teams to integrate quality principles into all processes and product life cycles.
- Stay current with relevant regulatory changes and industry best practices to ensure continuous compliance and improvement.
- Participate in risk management activities to identify and mitigate potential quality and regulatory risks.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Biomedical Engineering) or related field.
- 3+ years of experience in a regulated laboratory or quality assurance environment.
- Strong understanding of Quality Management Systems (QMS) principles and applications (e.g., ISO 9001, ISO 13485).
- Demonstrated knowledge of regulatory requirements such as FDA 21 CFR Part 820 (Medical Device QMS) or other relevant industry standards.
- Proficiency in documentation control, non-conformance management, and CAPA processes.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory concepts clearly.
- Strong organizational skills, attention to detail, and problem-solving abilities.
- Ability to work independently and as part of a team in a fast-paced environment.
Preferred Qualifications
- Master's degree in a relevant scientific or quality-related field.
- Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Engineer).
- Experience with LIMS (Laboratory Information Management Systems) or other quality management software.
- Prior experience in the diagnostics, medical device, or pharmaceutical industry.
- Lean Six Sigma Green Belt certification.
Perks & Benefits
- Competitive salary and comprehensive health benefits package (medical, dental, vision).
- Generous 401(k) matching program to support your financial future.
- Paid time off (vacation, sick leave, holidays) for work-life balance.
- Opportunities for professional development, training, and career growth within a global organization.
- Tuition reimbursement program for continuous learning.
- On-site fitness center and employee wellness programs.
- Employee stock purchase plan, giving you a stake in our success.
- Collaborative and innovative work environment.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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