Reporting to the VP Quality, the Quality Assurance and Quality Control Engineer will be responsible for defining and maintaining MDR and ISO 13485 quality requirements for R&D, Manufacturing, Quality Control and Logistics of the iSTAR medical Device.

They will be responsible for supervising the QC team, as well as actively taking part in process improvement initiatives and acting as a strong contributor for the compliance and efficiency of the Quality Management System. The engineer will be a key contributor to suppliers and internal audit processes.

Responsibilities:

• Support and interact closely with R&D and Manufacturing for verification and validation. Quality controls activities:

o Write product Verification & Validation (V&V) master plans

o Support execution of V&V Master plans and prepare Master V&V reports

o Define process and product validation/verification protocols

• Develop and maintain the QC activity plan and activities, manage QC team.

• Validate QC equipment and methods

• Support Manufacturing for qualification and validation of equipment, tools and processes

• Represent Quality function at Design Reviews and Risk Analysis

• Manage non-conforming products, CAPA (related to product and mfg process) and Change Control (related to product and mfg process).

• Responsible for the product release (Raw Material, Semi-Finished and Finished Goods)

• Monitor QA and QC activities through meaningful metrics and KPI

• CAPA process Owner in eQMS

Profile:

Education

• BS/MS in Bio-Medical or Mechanical Engineering (or similar experience)

Languages

• English and French (other language is an asset)

Professional Experience

• 3-5 years demonstrated experience in medical device engineering, ideally in quality management, from development to production with excellent ISO 13485, Risk Management and statistical methods.

• Experience in operator team management

• Previous experience in development or production of implantable medical device would be a plus

Personal Skills

• Ability to communicate and influence effectively to all levels of the organization.

• Flexible and adaptable

• Hands-on and result oriented

Travel

Max 10%

Offer:

The consultant position is based in Belgium (Wavre) and has an international scope. 

Headed by an experienced management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven track records in the pharmaceutical and medical device industries.

We have an agile scale-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.