QA Manager Sweden

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Quality & Regulatory

• Gothenburg
• Hybrid

QA Manager Sweden

We are searching for a structured and collaborative QA leader with a genuine passion for people, quality and processes.

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 healthy baby.
QA Manager Sweden
We are now looking for a QA Manager Sweden to lead our Quality Assurance team and ensure our quality management system continues to meet the highest standards in the medical technology industry. This is a permanent position based at our headquarters in Högsbo, Gothenburg, and reports to the Global Head of QA & QC.

About The Role
As QA Manager, you will lead a dedicated team of four QA Specialists responsible for maintaining and developing our Quality Management System (QMS) in accordance with applicable regulations and standards. You will act as the Management Representative and ensure compliance, readiness for audits and inspections, and continuous improvement across our operations.

Your leadership will be key in fostering a strong quality culture and supporting our employees in translating quality principles into everyday practice. You will also collaborate closely with functions such as Regulatory Affairs, Production, Supply Chain, and R&D to secure smooth product releases and ensure quality in all stages of our value chain.

Main Responsibilities

• Lead, coach, and develop the QA team in Sweden (currently 4 specialists)
• Maintain, improve, and ensure compliance of our Quality Management System (QMS)
• Act as Management Representative for top management
• Approve and release finished goods and raw materials
• Oversee and support audits, deviations, CAPAs, and change control
• Drive and deliver quality related training and competence development
• Partner with leadership to strengthen our quality culture and continuous improvement mindset
• Collaborate with other sites and global QA functions to harmonize processes and share best practices

Your Background

• University degree in life sciences (e.g., chemistry, biology, pharmacology, medicine, or similar)
• At least 5 years' experience in quality management or quality assurance within MedTech, Pharma, or Life Science
• Solid understanding of ISO 13485 and related regulatory requirements
• Experience in aseptic production or sterile techniques is highly meritorious
• Previous leadership experience and the ability to coach, empower, and develop a team
• Fluent in English and Swedish

About You
You are a structured and collaborative leader with a genuine passion for people, quality and processes. You enjoy leading others through change, promoting accountability, and helping teams grow their competence. You combine a strategic view with operational understanding and are comfortable taking decisions that balance compliance, efficiency, and continuous improvement. You thrive in a dynamic, innovative, and regulated environment — and see quality as a shared responsibility across the organization.

We Offer

• An opportunity to lead and shape the QA function in a global company enabling reproductive health
• A role that combines leadership, compliance, and continuous improvement
• A collaborative culture that values innovation, learning, and integrity
• Competitive benefits and a modern workplace in Gothenburg

We will be evaluating applications on a regular basis so please apply asap, but no later then October 30th.

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 support our customers by improving their clinical practice for the patient's outcome of 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.
Department Quality & Regulatory Locations Gothenburg Remote status Hybrid Employment type Full-time

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 1,100 people worldwide, headquartered in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 125 countries, through our own presence in more than 25 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 enable people to fulfill the dream of having a healthy baby.

The Vitrolife AB (publ) share is listed on the Nasdaq Stockholm.

Quality & Regulatory

• Gothenburg
• Hybrid

QA Manager Sweden

We are searching for a structured and collaborative QA leader with a genuine passion for people, quality and processes.

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