Quality Manager

We are looking for a motivated quality manager to join our team in Brazil!

What you will do

  • Manage the activities of the quality management system (QMS) department 
  • Develop and maintain the QMS under regulatory standards and requirements.
  • Review quality management, reporting actions to top management
  • Participate in internal and external audits (ISO 13485; ANVISA RDC 665/22; customers; EU NB)
  • Manage CAPA system
  • Be responsible for the go/no go gating of products and processes (working directly with the research & development and process engineering departments)
  • Work on developing the product, ensuring that the decision-making is aligned with the requirements of the QMS
  • Change the production process as necessary, ensuring that decision-making is aligned with the requirements of the QMS
  • Responsible for the Historical Record of the product
  • Complaint documentation 

Your profile

  • Knowledge of regulatory standards (ISO 13485; ANVISA RDC 665/22) and product development (design and validation checks)
  • Fluency in English and Portuguese is required
  • Knowledge of the advanced Office package
  • Knowledge of and experience with QMS in the medical industry (standard implants, plates, and screws)
  • Experience with internal and external audits (ISO 13485; ANVISA RDC 665/22) and CAPA
  • Mechanical engineering degree or similar
  • Ability to deal with and understand technical difficulties related to the areas of expertise
  • Ability to work collaboratively with other technical departments to proactively and pragmatically bring solutions within regulatory standards
  • Ability to monitor the QMS through effective reports to senior management
  • Ability to represent the company in audits
  • Critical and analytical mindset
  • Flexibility
  • Problem-solving ability by identifying the root cause and proposing appropriate actions

Location and type of contract

  • Brazil
  • Full-time

Share on:

Share on Facebook
Share on Twitter
Share on LinkedIn
Share with Pocket

Curious to learn more about this position?

Reach out to our team to get the answers to your questions.

Get in touch

Two women smiling and looking at a 3D-printed part

Working at Materialise

Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

Benefits

Having a healthy work-life balance

When creating a better and healthier world, a good place to start is with yourself. That’s why we encourage our employees to stay fit both physically and mentally by offering sports workshops and flexible hours with the possibility of working remotely.

Personal growth and career opportunities

Materialise invests in people and want to see them grow in a career that fits them best. We offer personal training to every employee, so they can access every available career opportunity.

Team building

It’s also important to enjoy working at Materialise. With initiatives such as memorable team-building activities, lively after-work drinks, and team lunches, we’re building a work environment in which our employees feel good.

Innovation is key

Innovation isn’t an empty word at Materialise. We create and deliver high-tech solutions in additive manufacturing. Innovation and leadership by our employees is both encouraged and rewarded.