Medical Quality Engineer

We are looking for a driven colleague who is passionate about quality, customer satisfaction, compliance and continuous improvement and have a significant part in bringing our organization to the next level for medical.
You will be supporting onboarding large new medical customer(s); being a bridge between Quality Assurance/Customer and Operations.

If you enjoy working in a challenging international environment and have work experience in a (medical) quality minded environment, please read on and explore if we are a match!

Here’s a glimpse of what you’ll do:

• Coordinates with other departments to ensure quality standards are maintained for medical customer(s);
• Identifies and escalates to Business Unit Management and/or Quality team if quality issues arise;
• Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Procedures in the organization
• Resolves quality related issues, report and (trend)analyses and advises on process improvements to ensure quality standards and customer requirements are maintained;
• Develop/gather content for training programs for internal users in subjects related to Customer requirements, Regulations or Quality Systems
• Responsible for documenting risk management for medical production lines and/or processes;
• Participates in establishing quality systems, compliance procedures, and quality objectives for medical customer(s);
• Take part in customer's, process and certification related audits. Ensures compliance with ISO 13485 standard, MDR (/FDA) and/or other applicable quality system regulations;
• Works closely with other members of the Quality team to set and achieve departmental goals.
• Setup and supervise the Medical Quality Control Team (3.0 FTE)

What you’ll need to have to be successful and happy in this role:

• Education and/or experience equivalent to a Bachelor's degree in Quality Engineering or a related field;
• Work experience in a (medical) quality minded environment, advice Managers on related topics and help create awareness;
• Experience with ISO 13485 (including software V&V is a plus), MDR (FDA is a plus)
• Capability to quickly absorb knowledge on related topics, methods and tools;
• Deal with resistance and able to question/understand the stakeholders and apply appropriate tactics;
• Fluent in English (written and oral);
• Pro-active, action oriented problem solving and analytical skills.

What do we offer:

Flex offers a challenging job and opportunities for development in a dynamic and growing international company. We offer an attractive and competitive remuneration package based on your education and work experience. In consultation with your manager, you make agreements about your personal development, focused on your job and ambitions and will receive all necessary guidance and support.

Are you interested?
And do you want to apply? Please share your CV and motivation letter trough this link.