Incoming Quality Control (IQC) Specialist

Incoming Quality Control (IQC) Specialist

Are you looking for a role in a company that makes a difference every day through its innovative products? We are looking for an Incoming Quality Control (IQC) Specialist located in our Global headquarter in Mölnlycke, Sweden.

Who we are

Our vision at Breas is to provide innovative solutions that enable people
with chronic respiratory conditions to live life to the fullest.

About Breas

Breas Medical was founded in 1991 in Gothenburg, Sweden, Breas Medical has become one of the global leaders in Home Mechanical Ventilation, Airway Clearance and Sleep therapy. Our vision is to provide Better breathing and quality of life to respiratory patients around the world and to help patients transition from Hospital to Home. Breas is headquartered in Sweden and has subsidiaries in the UK, Germany, Spain, USA and China. Together with network of highly specialized distributors, we serve over 40 countries worldwide. The Breas brands Vivo, Nippy, Clearway and Z1 are widely recognized and appreciated for their performance, ease of use and attractive design. Breas has approximately 200 employees, 50 of which in the USA. Our focus is first and foremost on the patients and customers we serve. We highly value our relationships, never compromise on quality, continuously improve customer support and expand our clinical excellence program consisting of study days, webinars, educational videos, symposia and clinical research. We work closely together with key opinion leaders around the world to stay updated on the latest clinical insights. All Breas products are designed to fulfil our vision and to help patients transition from Hospital to Home. We strive to become a total solution provider offering a broad range of products, from smart CPAPs to Bi-levels, NIV ventilators, Life-Support ventilators and Airway Clearance devices. Add to that a growing range of Accessories and Cloud solutions.

What we are looking for

We are looking for an IQC Specialist in the Göteborg area of Sweden.

If you love to work hands-on with Quality and make sure that the products are all good from the very beginning, here is your chance to contribute to better breathing and quality of life for patients worldwide.

As an IQC Specialist, you will join Breas Medical's Distribution team in Sweden, which is part of our Global Operations with colleagues and suppliers in Sweden, UK, US, China and other countries.

Your focus is to make sure that our very high-quality expectations are met for all products and materials from our qualified suppliers. The materials are used in life-support medical equipment.

You will work closely with IQC colleagues as well as colleagues from Distribution, Production, Sourcing, QA&RA and R&D to receive, inspect and release purchased materials for Production. You will also handle nonconformities towards suppliers and the Sourcing team. You will develop our inspection methods to continuously improve our quality.

The main types of inspection will be for plastics and electronics. You will be using our modern IT applications JDE ERP, JIRA, SharePoint 365 etc.

We are certified to MDSAP, ISO 13845 and MDD/MDR, and you will be part of the team to prepare the annual audits, as well as any unannounced audits.

As an IQC Specialist you are responsible for incoming inspections, special inspections of materials on request, configuring and maintaining inspection criteria in the ERP system, documenting and reporting results of inspections.

Maintain inspection criteria (ITD) in ERP system according to the Essential Parts Classification.

Conduct inspections according to ITD to ensure that the quality of the incoming goods are fulfilled before releasing materials into production warehouse.

Documents inspection results by completing reports, file certificates of conformity (CoC) and material test and inspection reports

Report and handle nonconformities according to Nonconform material procedure.

Initiate Supplier Corrective Action (SCAR) towards Sourcing and affected supplier.

Conduct First Article Inspections (FAI) and on request, special inspections from R&D.

Experience you will bring

• Formal qualifications include a relevant education in technical, medical, engineering or other relevant field, plus at least 3 year's relevant experience, preferably from medical devices or other industries with high quality demands.
• You have experience of QMS, such as ISO 13485, MDSAP, ISO 9001 or similar.
• You are very organized and can work independently to complete your tasks and follow up that you get needed responses.
• You have a hands-on working style and can combine careful attention to detail with efficiency and sense of urgency, to get things done.
• You are service minded without compromising with quality requirements.
• As you will work with both international and local personnel, both spoken and written Swedish and English are a must. Additional languages in particular Chinese is a plus.
• You have good communication and documentation skills.