Group Quality Leader: Scalable QMS & AI/ML (MedTech)

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

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