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Design Quality Assurance Engineering

Gothenburg, SE

Ref. number:  1203

WORKING AT MÖLNLYCKE

 

Are you looking for a great career and want to make your mark?

 

Please keep on reading and don’t just take our word for it. We’ve interviewed colleagues around the world about their jobs, and they all share that the Mölnlycke unique culture and the Mölnlycke people and it is simply A great company to work for!

 

Could you help improve healthcare outcomes around the world?

If the answer is yes, you think just like us and should apply for this exciting opportunity that we have below.

 

Do you want to be part of our Design Quality Assurance team helping us to guide and support our stakeholders on how to navigate within Design and Change controls to develop safe, functional and compliant healthcare products. We are now hiring a Design Quality Assurance Engineer to join our team.

In this role you will be involved in many interesting projects, working in cross-functional teams and be part of problem-solving in an environment where we encourage you to also influence our journey moving forward.

 

Do you see Quality Assurance as a really important part of the product development and product change process and would you like to share your knowledge and ideas with us? Then maybe you are the new team member that we are looking for.

 

Your responsibilities

 

In this role you will proactively support the R&D organization in product development or product change projects, addressing quality challanges and be part of optimizing the R&D process. We support the implementation, maintenance and continuous improvement of the quality management system in alignment with applicable internal and external policies, standards and regulations.

 

Typical tasks are to review and approve relevant documentations and to proactively support and advice in product development and change projects to enable an efficient project execution that will result in a safe, functional and compliant product ready for the market. You are a person who people will come to for advice and support in these questions and you will help us to secure compliance in our product development projects and product changes. 

You will also participate in external and internal audit activities to support global internal audit program.

 

Who are you?

 

We see you as someone that have the ability to structure the design work and that can give guidance in how to do the right thing from the start and to become a person who people would come to for advice. You have a coaching approach and be able to have many things ongoing at the same time. It will also be crucial to have an holistic view at the same time as you will also need to have the eye for details when you read and review documentations.

 

You are someone who thinks proactively, have an analytical mindset and is not afraid of leading change. You like challenges and that things sometimes move fast.

 

Your qualifications/experience

 

  • Academic background in engineering, life sciences, medical biology or chemical area or other relevant area or similar.
  • At least five years of working experience within the Design quality area, R&D or the broader Quality area, preferable from the medical device, pharmaceutical, in vitro diagnostic, biologics or food industry.
  • Knowledge in applicable medical device / pharma / biotech quality system regulation e.i. ISO 13485, MDD/MDR, FDA 21 CFR part 820 and ISO 9000
  • Experience from work in an international organization or environment will also be an advantage.
  • Analytical Skills
  • Fluent in English and preferable Swedish

 

We welcome your application and look forward hearing from you. We will evaluate candidates continuously, don’t hesitate to send us your application. We will contact only selected candidates.

 

About Mölnlycke

 

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to home care, proving it every day.

We specialise in:

•                        Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®

•                        Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients

•                        Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves

 

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.