Quality Management System Specialist

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

A healthier future. It’s what drives us. At Roche, we are committed to advancing science, ensuring the highest quality in diagnostics, and giving everyone more time with the people they love. Quality isn't just a requirement; it's a competitive advantage and every patient's right.

Are you an experienced Quality Management System (QMS) Specialist ready to drive QMS implementation and adherence within our Diagnostics commercial affiliate in Finland, while also supporting Denmark, Norway, and Sweden? We are seeking a dedicated professional with deep, practical knowledge of QMS in the healthcare industry to manage critical operational tasks and ensure our local processes meet all required standards. This role operates within a dynamic Nordic subregional network.

The main responsibilities

This role is centered on ensuring continuous quality assurance, operational excellence, and local adherence to global standards across our Finnish affiliate, while actively contributing to our Nordic team.

• Act as the Subject Matter Expert (SME) for our Quality Management System (QMS). You will be responsible for implementing, maintaining, and continually improving local processes to ensure adherence to Roche policies and the ISO 9001:2015 standard.

• Drive quality improvement initiatives, conduct internal audits, and represent Roche during ISO 9001 external audits.

• Fulfill key local regulatory functions as the Local Safety Officer (LSO) and Site Security Officer (SSO) for the Finnish affiliate, and support the local Safety, Health, and Environmental (SHE) duties.

• Track and report key Quality metrics (KPIs), ensuring timely corrective and preventive actions when necessary. You will also promote a culture of quality through regular training across the organization.

• Lead cross-functional quality-focused projects, develop process improvements, and actively participate in activities related to our Information Security Management System (ISMS).

Who You Are

You are a proactive, analytical professional ready to take ownership of complex quality responsibilities in a fast-paced environment.

• You hold a degree in Life Science, Business Administration, or a related field, and have a minimum of 3 years of professional experience in a Quality or Regulatory role within the Diagnostics or MedTech industry.

• You are a Subject Matter Expert (SME) in ISO 9001:2015 and have a strong, practical understanding of operating a Quality Management System (QMS) within a commercial healthcare context.

• You are a native Finnish speaker with excellent verbal and written English skills.

• You have excellent analytical skills to handle large datasets and resolve complex quality issues independently. You are an experienced business partner with strong communication and presentation skills, capable of building trust and driving quality initiatives.

• Certification as an internal auditor and familiarity with ISO 27001, IVDR/MDR, and other relevant industry requirements is a distinct advantage.

What we offer

• A competitive salary and benefits package, including ample development opportunities.

• Global environment with flexible work arrangements in an agile setting

Your Application

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A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.