Quality Assurance Manager

CooperSurgical

Venlo

On-site

EUR 60,000 - 80,000

Full time

14 days+

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Job summary

A leading medical company in Venlo is seeking a Quality Assurance Manager to ensure compliance with quality standards and manage quality systems. This role involves collaboration with local and regional teams, as well as establishing quality assurance procedures. The ideal candidate has over 5 years of experience in a similar managerial role and a strong background in quality management systems. This position offers a full-time employment opportunity with a growth-oriented environment.

Qualifications

5+ years of experience in a managerial role within medical device or pharmaceutical.
7+ years managing a Quality management system.
Experience with an international setup.
Fluent English (spoken and written) is mandatory.

Responsibilities

Ensure maintenance of site quality systems in a state of control.
Develop a culture of continuous improvement.
Establish and maintain quality assurance procedures.
Conduct internal and external audits.

Skills

Problem-solving

Structured approach

Good communication

Team player

Flexibility

Education

MSc in Science or Engineering

Tools

MS Office

Job description

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Direct message the job poster from CooperSurgical

Intl. Sr. Business Partner TA, EMEA & APAC @ CooperSurgical

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.

Position

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.

Your key responsibilities

Ensure maintenance of site quality systems in a state of control by ensuring continuous adherence to Good Manufacturing, Distribution and Service Practices.
Develop a culture of continuous improvement by developing and implementing strategies that achieve measurable results such lowering product scrap and returns.
Establish and maintain quality assurance procedures to ensure products meet required GXP
Ensure documentation and filing according to industry standard
Develop, establish, and monitor KPIs and drive initiatives to improve this quality metrics at the Distribution Center.
Conduct internal and external audits

Your Qualifications

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

We can offer a challenging position within a dynamic, globally leading, high growth company. You will work together with competent colleagues in a positive that welcomes people of all views and backgrounds and provides countless ways to grow and develop.

To ensure we continue improving the quality of treatments for women and families, we offer roles that challenge individuals, helping them grow. To make this happen we provide high-quality training, and through collaborative project work and peer support, we believe our work environment helps to nurture talent enabling everyone to excel.

Seniority level