Support review and approve changes, equipment qualification and validation.
Facilitate sharing of regulatory & compliance expectations.
Facilitate presentation & support for audits & inspections.
Eliminates non-value-added practices.
Requirements
Bachelor's or master's degree in a Quantitative/Scientific/Technical discipline.
+4 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 such as ISO 13485, ISO 14971:2019, IVD Regulation (EU) 2017/746, FDA 21 CFR part 11 and 820 as well as 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.
Thrive working cross-functionally with people at all levels of the organization
Flexible, systematic, and engaged team player
Full fluency to read/write/speak in Danish and English on a business level.
On a personal level, you are process and detail oriented as well as a proactive team player who's capable of working cross-functionally with people at all levels of the organization.
Benefits
An inspiring and social environment with 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.Please note Job level will be adjusted according to relevant experience and qualifications.Additional DetailsThis job has a full time weekly schedule.Travel Required:NoShift:DayDuration:Over 12 MonthsJob Function:Quality/RegulatoryFlexible scheduleEquity / stock optionsPerformance bonus
Additional Information
Job Description
We are looking for a new team members. Join us!
As a manufacturing QA specialist in our department, you have the opportunity to work closely with competent and engaged QA-colleagues as well as manufacturing departments related to all process steps from raw materials in, production of intermediates to finished products release used for in vitro diagnostic of cancer.
We focus on good collaboration between line of business and, priorities early QA involvement in projects and tasks as well as presence in production including on-the-floor sparing, process confirmation and "go-look-see".
You will, together with a highly competent QA team take responsibility to ensure compliant and high-quality products, which imply involvement in a broad range of activities such as nonconformities, changes, equipment qualification and validations as well as continuous identification and implementation of improvements in production and QA processes. Producing reagents for in vitro diagnostic of cancer is a complex task where you will need to navigate in regulatory good manufacturing practices and authorities' expectations while ensuring timely and effectively products to patients.
Agilent · Denmark