Quality Assurance Specialist
Vitrolife Sweden AB / Organisationsutvecklarjobb / Göteborg
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hela Sverige Vitrolife Group is a global provider of medical devices and genetic services with a powerful vision - to fulfil the dream of having a healthy baby!
We are now offering the exciting possibility to join our Consumables Business Area and to be part of our Quality Assurance Team.
The Consumables Business Area develops, manufactures, and distributes products to more than 110 countries from three sites; Gothenburg, Denver and San Diego. Our raw material suppliers are located globally. We also have contract manufacturing in Asia. The business area consists of three business units, Media, Disposables Devices and Genomics. The turnover in 2022 was 1.339 MSEK and is 41% of the total Vitrolife Group turnover. Consumables have colleagues all over the world from the US to Australia. The product line covers most steps in the IVF process. Examples of key products are Ovoil, EmbryoGlue, G-IVF, Rapid-I, the Sense needle, micromanipulation pipettes, IVF approved labware and EmbryoMap, setting a standard for quality and safety.
The job
We are now looking for a highly motivated and experienced Quality Assurance Specialist to join our team. You will play a critical role in ensuring that our medical devices are safe, effective, and compliant with all relevant regulations and standards. You will work closely with cross-functional teams to ensure that quality standards are upheld throughout the product development lifecycle.
Responsibilities:
Develop and implement quality assurance processes for medical device products
Conduct risk assessments and root cause analyses to identify and mitigate quality issues
Perform audits of manufacturing processes and supplier quality systems
Review and approve design control documents, including specifications, design inputs, and design outputs
Ensure compliance relevant standards and regulations (ISO 13485, MDR, etc.)
Maintain quality records and documentation, including complaint investigations and corrective action plans
Participate in the development and implementation of training programs for employees on quality assurance procedures and best practices
Release of products to the market
Requirements:
Bachelor's degree in a relevant field (engineering, life sciences, etc.)
Minimum of 3-5 years of experience in quality assurance in the medical device industry
Strong knowledge of international quality standards (ISO 13485, etc.)
Experience with risk management and root cause analysis methodologies
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Ability to work independently and as part of a team
English in writing and speaking
If you are a dedicated Quality Assurance Specialist with a passion for ensuring the safety and efficacy of medical devices, we encourage you to apply for this exciting opportunity. We offer a dynamic work environment where you will have the opportunity to be part of the powerful vision - to fulfil the dream of having a healthy baby!
This is a permanent, full-time position based in Gothenburg. The position will include business travels to other Vitrolife sites and suppliers.
Contact and application
Interviews will take place on an ongoing basis; the position may be filled before the last application date so make sure to apply as soon as possible.
For any questions, please contact QA Director Lars Ketilsson, +46 701 64 88 59.
We look forward to receiving your application!
More about Vitrolife Group
Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We are supporting our customers by improving their clinical practice and the outcome of the patient's fertility treatment. Currently, we are approximately 1,150 people worldwide, headquartered in Gothenburg, Sweden.
Vitrolife Group's products and services are available in more than 110 countries, through our own presence in 30 countries and a network of distributors. We are a sustainable market leader and aim to be the preferred partner to the IVF-clinics by providing superior products and services with the vision to fulfil the dream of having a baby. The Vitrolife share is listed on the Nasdaq Stockholm.
Så ansöker du Sista dag att ansöka är 2023-05-14
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Vitrolife Sweden AB (org.nr 556546-6298)
Gustaf Werners gata 2 (
visa karta)
400 92 VÄSTRA FRÖLUNDA
Jobbnummer 7679201
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