Jobs in life sciences

QA consultant (medical devices)

Ref.
Function: You will perform consulting activities at customer’s site (implementation or improvement of QMS in agreement with ISO13485 and IVD/MD regulations).
Location: Offices at Ghent, projects at customer’s site (Flanders). Homework permitted.

The company:

Talent & content

MindCapture has its offices in Ghent and Antwerp and focuses on innovative environments and future oriented life science talents. We connect people to 21st century company activities that thrive innovation and impact. We provide staffing (talent) and consultancy services (content). 

MindCapture offers a range of services to support companies or healthcare institutions in quality management, data management and business development. The MindCapture consultants are experts in improving or updating actual quality plans (QualityCapture), adding digital layers to internal and external activities (DataCapture) and sharpening business plans for future growth (BusinessCapture). MindCapture's focus is set on labs, CROs, biotech, pharma and medical devices.

Our QualityCapture team consists of experienced quality management consultants who developed their hands-on experience and expertise over the past 15 years. We can help you with a specific quality management request or we can offer a total, customized solution. We are highly skilled in the area of medical devices, medical labs, healthcare services, CRO, pharma and biotech.

Job description:

  • Develop quality system processes in line with ISO13485 and the applicable regulation.
  • Write procedures and/or assist the manufacturer by providing input into and reviewing of their writing of documents. 
  • Perform gap assessments, internal audits and supplier audits.
  • Assist manufacturers in quality system activities, such as management review, supplier assessment, customer feedback and other. 
  • Train manufacturers’ personnel in quality system procedures.
  • Contribute to any other quality assurance activity, such as validation.
  • In certain cases, act as an outsourced quality assurance manager. 

Requested competences and skills:

The perfect candidate (M/F) has a degree in sciences or engineering and has an excellent understanding of Quality Assurance in the Medical Device environment as demonstrated by a minimum of 5 years of experience as an employee in a MD or IVD company (ISO13485 preferred; ISO17925/ISO15189 or even other ISO norms are accepted). We welcome applications of candidates with a longer (+3 years) experience in QM. Knowledge of quality and regulatory related issues in the fields of IVD development and manufacturing, sterilization, biocompatibility, electronic safety and EMC is a strong advantage. Our candidate fluently communicates (speaking + writing) in Dutch and English, and preferably other languages. He/she enjoys working in an international context and is willing to travel to customers, mostly within Belgium. He/she likes variation and handles several projects at the same time and understands that working in a small team requires a flexible attitude.

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