Group Manager Quality

RaySearch Laboratories; Stockholms kommun; On-site; SEK 900,000 - 1,200,000; Full time

Benefits offered by this job

Role at exciting time

Modern office in Hagastaden

In-house gym

Yoga classes

Lunch buffet

Daily fika

Rooftop terrace with 360° view

Competitive compensation package

Job summary

RaySearch Laboratories is seeking a Group Manager Quality to lead the Quality function within the Quality & Regulatory Affairs Department in Stockholm. You will guide a three-person team and drive the evolution of a lean, scalable QMS, aligning processes with the business to enable confident and swift development.

You will oversee activities including CAPA, audits, change control, document management and supplier quality, while shaping quality in AI, ML and data management, and ensuring

Qualifications

• An MSc or BSc in engineering, life sciences or a related field relevant to medical device quality and regulatory affairs.
• Extensive experience in Quality Management in the medical device industry.
• Strong ISO13485 QMS expertise, including MDSAP and FDA QMSR requirements.
• Solid knowledge of EU MDR and ISO14971 risk management.
• Lead auditor experience with audits, internal and external.
• Proven leadership experience leading and developing teams.
• Very good command of English, both written and spoken.

Responsibilities

• Drive evolution of the QMS with a focus on simplifying processes and enabling scalability as the organization grows.
• Leading and developing the quality team through clear direction, coaching and support.
• Overseeing key operational quality activities, including CAPA, nonconformance management, change control, internal audits, document management and supplier quality.
• Supporting the selection and implementation of an eQMS solution.
• Contributing to quality and compliance processes in AI, ML and data management.
• Ensuring compliance with ISO 13485, MDR Article 10, MDSAP and QMSR, and supporting regulatory inspections and audits.
• Partnering with cross-functional teams so that quality practices enable efficient ways of working.

Skills

Quality management

ISO13485

MDSAP

EU MDR

ISO 14971

Lead auditor

Leadership

English fluency

Education

MSc or BSc in engineering or life sciences

Job description

Do you want to build something new, not just maintain what already exists? A lot is happening in RaySearch’s Quality & Regulatory Affairs department right now, and RaySearch is looking for a business-minded Group Manager Quality who will lead a team, shape the next phase of quality excellence and drive development forward in a medical device company where innovation and compliance go hand in hand.

Responsibilities

As Group Manager Quality, you lead the Quality function at RaySearch. You are part of the Quality & Regulatory Affairs Department, report to the Director of the department, and lead a team of three. This is a role with great opportunities to build new, influence and drive change. You will shape how quality works across the organization and evolve an established QMS into something lean, scalable and fit for purpose, so the business can move with both confidence and speed. From the selection of a new eQMS to quality processes for AI and machine learning, you will help set the direction. Your main responsibilities include:

• Driving the continued evolution of the QMS, with a focus on simplifying processes and enabling scalability as the organization grows
• Leading and developing the quality team through clear direction, coaching and support
• Overseeing key operational quality activities, including CAPA, nonconformance management, change control, internal audits, document management and supplier quality
• Supporting the selection and implementation of an eQMS solution
• Contributing to quality and compliance processes in emerging areas such as AI, machine learning and data management
• Ensuring compliance with ISO 13485, MDR Article 10, MDSAP and QMSR, and supporting regulatory inspections and audits
• Partnering with cross-functional teams so that quality practices enable efficient ways of working

Your background

• An MSc or BSc in engineering, life sciences or a related field relevant to medical device quality and regulatory affairs
• Extensive experience in Quality Management in the medical device industry
• Strong expertise in ISO 13485 and medical device QMS, including MDSAP and FDA QMSR requirements
• Solid knowledge of EU MDR
• Strong understanding and practical application of ISO 14971 risk management
• Lead auditor experience, including planning, conducting and leading internal and external audits
• Proven leadership experience, including leading and developing teams
• Very good command of English, both written and spoken

It is meriting if you have experience implementing, optimizing or validating eQMS solutions. Experience with medical device design and development, including software lifecycle processes under IEC 62304, is also meriting, as is experience with cybersecurity requirements, AI/ML-enabled medical devices, or a Lead Auditor certification.

You are a business-minded, hands-on and collaborative leader who enjoys improving processes and solving operational challenges. You have a clear sense of what good quality looks like, and you know how to implement it so that it supports the business rather than slowing it down. You can tell critical risks from unnecessary complexity, and you naturally build strong cross-functional relationships. Most importantly, you are motivated by the opportunity to make a visible impact and play a key role in shaping a modern, scalable quality organization.

RaySearch offers

• A key role at an exciting time, when a lot is happening in the Quality & Regulatory Affairs department
• Great opportunities to build new, influence and drive development forward, and to lead a team shaping a modern, scalable quality organization with visible impact across the company
• A modern office in Hagastaden, Stockholm’s Life Science Hub, with an in-house gym, yoga classes, a lunch buffet, daily fika and a rooftop terrace with a 360-degree view of Stockholm
• A competitive compensation and benefits package