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Solliciteren

Plaats

Utrecht
Utrecht
Nederland

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2025-04-07

Online tot

2025-06-06
EUR 15.00 HOUR

QA Manager/senior Manager

Panda International
Utrecht Utrecht
Andere
2 weken geleden

Role: Senior QA Manager – Design Controls We are partnering with a global Medical Device company seeking a QA Manager specializing in Design Controls. This is a strategic leadership opportunity to ensure compliance in product development, risk management, and quality assurance processes while driving cross-functional collaboration to bring high-quality medical devices to market. &##Scope: Design Quality & Compliance As a QA Manager, you will oversee design control activities, risk management, and regulatory compliance for finished medical devices. You will lead quality assurance initiatives, mentor a QA team, and drive process improvements to enhance efficiency and compliance with ISO 13485, MDR 2017/745, PPE, and other applicable regulations. Oversee design control activities, ensuring compliance with ISO 13485, MDR, PPE, and ISO 14971 risk management, integrating them into product development. Manage design history files (DHFs) and ensure robust documentation across design reviews, verification, validation, and design transfer. Supervise product testing and ensure compliance with EU regulatory requirements. Lead a team of 7 direct reports (remote team), mainly QA engineers. Lead, mentor, and develop the QA team, fostering a culture of quality and driving continuous improvement initiatives. Develop and track quality metrics, reporting to senior management while ensuring alignment with corporate and regulatory standards. Support internal/external audits, CAPA management, and regulatory compliance, collaborating with Regulatory Affairs on EU requirements. Investigate defective product trends and customer complaints, coordinating supplier quality management and decision-making on deviations. Provide QA support for EU market tenders and product management. Degree in Life Sciences (Biology, Chemistry) or Engineering with 6+ years of experience in the Medical Device industry. Expertise in design controls, risk management, and regulatory compliance. Track record in leading and developing a QA team. Ability to manage complex quality operations in a fast-paced environment. Fluent in English; French is a plus. Be part of a long-established Medical Device company that is growing rapidly and has a global expsoure. The company specializes in Class I and Class II sterilized and non-sterilized surgical products , offering an opportunity to lead and shape quality assurance in a dynamic and innovative sector. If you are an experienced QA Manager with expertise in design controls and regulatory compliance within MedTech, Life Sciences, or Pharmaceuticals, we’d love to hear from you! &##

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