QA & QC Assistant Vyškov

QA & QC Assistant

About Us:

CIMPAX, a leading Danish medical device manufacturer, is dedicated to delivering top-quality surgical products and outstanding customer service. We prioritize sustainability and safety, focusing on providing premium single-use surgical instruments to healthcare providers globally. We are passionate about our mission and committed to making a positive impact on the lives of not only the patients but also the staff in the operating room.

Our expertise lies in manufacturing electrosurgery and smoke evacuation products, laparoscopic instruments, and items for pain management, all tailored to meet the distinct requirements of healthcare professionals and their patients. Our products have gained a strong presence in more than 40 countries through close collaborations with global partners and distributors.

Position Overview:

We are seeking a dedicated and detail-oriented QA & QC Assistant to join our team. The successful candidate will play a crucial role in ensuring the quality and compliance of our cleanroom facility in Vyškov, Czech Republic. If you are passionate about maintaining high standards in a regulated environment and enjoy collaborating with cross-functional teams, we want to hear from you!

 Key Responsibilities:

• Conduct environmental monitoring and maintain accurate trend records.
• Oversee the monitoring system, including daily and monthly reviews, investigation of alarms, and implementation of corrective actions when necessary.
• Manage annual probe calibrations and provide training to employees on the use of the monitoring system.
• Review and analyse performance indicator data for the cleanroom facility to develop and implement quality and process improvements.
• Administer the validation master plan to ensure all validations are completed appropriately.
• Manage reference parts for production and implement necessary changes in production documentation.
• Assist in training, qualification, and monitoring of staff in cleanroom protocols, including access, gowning, hygiene, and behaviour.
• Collaborate with Quality, QMS, and Environmental Manager to update the QMS system.
• Work closely with QA, RA, R&D, and Production teams to assist with various tasks as required.
• Perform QC control of goods 

Qualifications:

• Engineer, Science Bachelor or similar
• Excellent analytical and problem-solving skills.
• Effective communication and teamwork abilities.
• The position is also suitable for graduates

What We Offer:

• Competitive salary and benefits package.
• 5 weeks’ vacation
• Opportunity to work in a dynamic, innovative industry in the healthcare sector.
• Flexible working hours
• Career development and growth within a rapidly expanding company.
• A work environment that promotes team spirit, collaboration, and a fun atmosphere.

How to Apply:

If you are interested in joining our team as a QA & QC Assistant, please submit your resume and a cover letter detailing your relevant experience to Quality and Environmental Manager Eva Hamplová.

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