CooperCompanies
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women’s healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women’s health care clinicians. More information can be found at .
At CooperSurgical we are currently looking to recruit a Quality Manager- for our Distribution Center (DC). In this role there will be one direct report and much cross- functional collaboration and stakeholder management with local, regional, and corporate CSI organizations.
You will be part of the CooperSurgical Regional Quality team, with direct reference to the Director of Quality Assurance OUS manufacturing, distribution, and service. The role is placed in Venlo, Netherland and is onsite.
Applicants must be eligible to work in Netherland and travel freely in EU, UK and APAC .
As Quality Manager , you will play a critical role in ensuring regulatory compliance, implementation, continuous improvements, and consistent performance of CSI quality management system requirements at Venlo DC site.
In this role, you will be the Quality subject matter expert of the end-to-end finished goods supply chain, enabling the distribution quality standards and regulatory compliance for the EMEA and part of APAC regions.
The Quality manager is responsible for providing quality oversight for area specific change controls, deviations and CAPAs and participate in and reviewing investigations.
It’s essential to ensuring that products received/stored/labeled/shipped from Venlo DC meet the required quality standards and customers’ expectations, in compliance with the requirements of the European (MDR) Medical Device Regulation 2017 / 745 on medical devices, European In Vitro Diagnostic Regulation (IVDR) 2017/ 746, ISO 13485 standard, including FDA CFR Part 820 Quality System Regulation.
As CooperSurgical have satellite distribution centers in Turkey, Australia /NZ and India, its important to work closely with these countries and be familiar with their local regulations.
This position requires a seasoned professional with a deep understanding of GMP, GSP, and GDP practices, excellent problem-solving skills, and the ability to collaborate across cross-functional teams.
You thrive in a dynamic environment and are comfortable juggling several complex tasks while keeping an eye on the details. You will work closely together with the Quality and Regulatory teams and relevant stakeholders, globally.
Responsibilities:
MSc in Science or Engineering
+ 5 years of experience from a similar role managerial role, preferable within medical device or pharmaceutical
+7 years managing a Quality management system
Experience with an international set-up
Problem-solving, structured, and systematic approach
Good communicator and team player
Robust and flexible mindset
Proficient level in MS office
Fluent English (spoken and written) is mandatory
