Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. Agilent enables customers to gain the answers and insights they seek - so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
Join us as a Manufacturing Quality Specialist to help us improve and shape the future of our operations! This role offers a unique chance to share your ideas and make a real impact! You'll become part of our collaborative team in Copenhagen, where knowledge-sharing and your professional growth are a top priority, supported by thorough training.
Working alongside dynamic manufacturing and R&D teams, you'll help ensure our products consistently meet the highest quality standards.
Key Responsibilities:
• Play a pivotal role in oversight of production-related changes, Non-conforming (NC) and Corrective and Preventive Action (CAPA) programs. Drive, teach, and mentor peers to ensure thorough investigations, root cause analysis, corrective/preventive actions, and verification plans occur.
• Lead and drive a collaborative culture that shares best practices, proactively partners across the organization, and mentors team members on Quality principles (both within and outside Quality).
• Integration of the principles of Lean methodology (GEMBA, Kaizen, Tier Metrics, etc.) to drive overall systemic Quality improvements.
• Work independently, or with teams, to find solutions to manufacturing quality related opportunities.
We are looking for an individual with the following background:
• University degree in a technical field.
• +2 years of work experience in the medical device or pharmaceutical industry
• Good knowledge of Medical Device Standards and Regulations (In-vitro Diagnostic Standards and Regulations , such as IVDR Regulation (EU) 2017/746, would be a plus!) Including: ISO 13485, ISO 14971 and Regulations governed by Medical Device Single Audit Program (MDSAP)
• Experience working with In Vitro Diagnostic and/or Medical Devices will be considered as a plus!
• Full fluency to read/write/speak in Danish and English
On a personal level, the ideal candidate will demonstrate strong verbal and written communication skills. They should be detail-oriented and a proactive team player, capable of working independently and collaborating cross-functionally with partners at all levels of the organization.
We offer:
• Permanent Contract and Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.
• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing, and sustain activities.
• An opportunity to make a significant impact and develop your skills in a world-class company that takes pride in developing innovative solutions for pathology labs worldwide to improve cancer diagnostics.
Please note Job level will be adjusted according to relevant experience and qualifications.
Additional Details
This job has a full time weekly schedule.Our pay ranges are determined by role, level, and location. 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. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent 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: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory