Quality Assurance Specialist

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby

Our company is seeking a highly drive and experienced Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, 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 life cycle.

Responsibilities:

• Develop and implement quality assurance processes for medical device products
• Conduct risk assessments, complaint investigations 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
• Review and approve process validation documents
• Maintain quality records and documentation, including corrective action plans
• Ensure compliance with relevant standards and regulations
• Participate in the development and implementation of training programs for employees on quality assurance processes and best practices

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
• Knowledge of ISO 13485, EU MDR 2017/745, USFDA 21 CFR Part 820
• 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 speaking and writing

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 competitive compensation packages and a dynamic work environment where you will have the opportunity to make a meaningful impact on the lives of patients.

We continuously review applications and the position might be filled before the deadline so do not hesitate in submitting yours!

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 personalised genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of a fertility treatment.

We are currently approximately 1 100 colleagues worldwide, with headquarters 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. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.