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Manufacturing Quality Assurance Specialist
2 months ago
As a Manufacturing QA Specialist at Agilent, you will be responsible for ensuring the quality of our products, from development to delivery. Your expertise in quality engineering and scientific methods will be essential in maintaining our high standards of quality and compliance.
Key Responsibilities:
- Apply advanced quality engineering and scientific methods to ensure product quality and compliance.
- Make decisions on quality and compliance issues with little guidance.
- Ensure site compliance with regulations, ISO standards, and local standard operating procedures (SOPs).
- Serve as a subject matter expert (SME) on quality processes.
- Lead improvement activities and improvement of standards within the quality management system.
- Support, review, and approve complex cross-functional investigations and root-cause analysis.
- Facilitate sharing of regulatory and compliance expectations.
- Facilitate presentation and support for audits and inspections.
Qualifications:
- Bachelor's or master's degree in a quantitative/scientific/technical discipline.
- +2 years of work experience in the medical device or pharmaceutical industry.
- Preferably experience working with In Vitro Diagnostic and/or Medical Devices.
- Strong knowledge and understanding of standards and regulations: ISO 13485, Regulation (EU) 2017/746, ISO 14971:2019, and regulations covered under MDSAP.
- LEAN mindset.
- Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
- Strong verbal and written communication skills.
- Results-oriented and willing to take accountability.
- Thrives working cross-functionally with people at all levels of the organization.
- Flexible, systematic, and engaged team player.
- Full fluency to read/write/speak in English on a business level.
We Offer:
- 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.
- A role among passionate colleagues, in a growth-oriented and inclusive environment. You will become part of a caring and fast-paced environment, built on integrity, sharing, and trust.
- Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.
