Manufacturing QA Engineer
Agilent Technologies
Glostrup or Copenhagen, Denmark
We are looking for a Manufacturing Quality Engineer to help us become even better in what we do. We are offering a phenomenal opportunity to contribute with ideas and have an influence on how we develop the future. You will be joining a collaborative team ready to share their knowledge and help you build your knowledge through support and comprehensive training.
With reference to our Manufacturing Quality Engineer, you will be part of a team that is responsible for ensuring products are manufacturing to the highest quality standards, while partnering with a dynamin manufacturing and R&D team.
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.
Qualifications:
- Bachelor’s or master’s degree in a technical discipline;
- +2 years of work experience in the medical device or pharmaceutical industry;
- Experience working with In Vitro Diagnostic and/or Medical Devices;
- Good knowledge of Medical Device and In-vitro Diagnostic Standards and Regulations. Including, ISO 13485, IVDR Regulation (EU) 2017/746, ISO 14971 and the Regulations governed by Medical Device Single Audit Program (MDSAP);
- Strong verbal and written communication skills;
- Full fluency to read/write/speak in English on a business level;
- Detail oriented as well as a proactive team player who’s capable of independently working cross-functionally with people at all levels of the organization.
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