Quality Assurance (QA) Specialist

☞ Andocor

看过: 100

更新日: 14-11-2025

位置: Hoogstraten Antwerp

类别: 质量保证/质量控制

行业: Medical Equipment Manufacturing

水平: Mid-Senior level

工作类型: Full-time

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工作内容

Andocor

Andocor is a Belgian company active in the field of cardiovascular surgery and anesthesiology. At our site in Hoogstraten, we manufacture high-quality cardiac catheters and cannulae.

Our commitment to scientific research and our endeavor to excellence and quality have propelled Andocor to successfully market and sell our innovative line of cardiac catheters and cannulae worldwide. This success is a result of applying high standards of manufacturing methods, highly-qualified scientists and production personnel. This cross functional team is cooperating side by side with specialists and doctors who are the ultimate judge of Andocor as their partner for better patient care.

Job Description

As Quality Assurance (QA) Specialist you will ensure that all related processes and procedures meet the requirements of applicable regulatory standards, the EU Medical device regulation 2017/745:

· Execute, maintain and improve the assigned Quality Management Systems (QMS) processes: Complaint handling, Change Control, Deviation and CAPA Management, Supplier Corrective Action Reports (SCAR) writing and follow-up with Suppliers, Internal Audit Program etc.

· Take an active role in QMS related projects and update related standard operating procedures (SP).

· Support during external Notified Body audits and follow up on any audit findings

· Work collaboratively with other areas to effectively investigate and solve quality issues and define CAPAs

· Act as quality responsible to support and train manufacturing personnel and to support projects to develop of new products

· Prepare gap analyses and actions to ensure compliance with new or updated ISO Standards and other guidelines (e.g. MDCG guidance documents)

· Support in the transition to MDR

Qualifications

· Degree in Pharmacy, Biological or Chemical sciences, Engineering or equivalent with preferably a minimum of 3 years of work experience within the medical device industry in Quality and/or Regulatory or similar industries like Pharma.

· Strong communication, organizational skills, ability to multi-task, prioritize and meet deadlines

· Fluent in both English and Dutch. French is an added value.

· Experience with the implementation and maintenance of quality management systems.

· Proficient understanding of ISO 13485, Regulation (EU) 2017/745.

· Understanding of requirements for product cleanliness, contamination control, bioburden testing, environmental monitoring and/or sterilization is considered a strong plus

· Experience with similar medical devices and/or sterile devices is considered a strong plus

· Experience as an internal auditor is considered as a strong plus.

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最后期限: 29-12-2025

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