Make your next move matter
At Mölnlycke, we believe that real impact starts with people. People who are bold enough to challenge the status quo. People who care deeply for their work, their colleagues, and the world around them. People who know exactly why they do what they do.

As a global medical solutions company, we design and deliver innovative products and services across wound care, operating room solutions, gloves, and antiseptics. Our mission is to advance performance in healthcare by supporting professionals, improving outcomes, and making a difference where it matters most.

This is a temporary opportunity to support our team during a period of parental leave. You'll bring your expertise to a team that values clarity, accountability, and collaboration. Your work will help us move forward efficiently and effectively.

In Wound Care at Mölnlycke, we help to prevent, manage and accelerate the healing of wounds.

QA-RA Specialist

Location: Elixhausen

Why This Role Matters

This isn't just a job, it's a chance to be part of something bigger. You'll join a global team with a shared mission: to advance performance in healthcare.

Here's how your contributions will shape meaningful outcomes:

• Plan and deliver post-market surveillance activities (PMS, PMCF, PSUR, SSCP), ensuring compliance and continuous improvement
• Coordinate documentation to support international market approvals (e.g. CFS, regulatory statements)
• Execute and document method validations to meet quality and regulatory standards
• Analyse quality and environmental trends, driving corrective and preventive actions
• Coordinate biocompatibility studies in line with ISO 10993 and maintain up-to-date documentation
• Maintain risk management activities in accordance with ISO 14971 across the product lifecycle
• Develop and maintain quality documentation, and support training across processes and procedures

What you bring

• Fluent in German (written & spoken)
• Degree in a relevant field (e.g. science or engineering)
• 3+ years' experience in QA, RA, or R&D within a regulated environment
• Hands-on experience with quality management systems and controlled documentation
• Experience with method validation (and/or qualification activities)
• Strong analytical skills with a structured, detail-oriented approach and ability to meet deadlines
• Experience in the medical device sector, including post-market requirements or regulatory processes is desirable
• Knowledge of biocompatibility or risk management standards (e.g. ISO 10993, ISO 14971) would be advantageous

What you'll get

Be part of a culture built on trust, care, and shared ownership.

Flexibility, wellbeing and benefits that reflect our commitment to you.

• Fixed term - 18 months
• May be eligible for annual bonus up to 5%
• 25 vacation days per year plus public holidays
• Wellbeing initiatives

Our approach to Diversity & Inclusion
We're building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people (from different cultures, ages, geographies, and genders) makes us stronger. It brings fresh perspectives, drives better decisions, and helps us deliver solutions that reflect the world we serve.

Inclusion isn't just a value, it's how we work, grow, and lead together.

About Mölnlycke
Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.

Our business is organised in the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.

Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health.

Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers

To apply for this position follow this link: https://careers.molnlycke.com/job/QA-RA-Specialist/10075-en_GB/

About this job

Employment type: Full Time (Permanent employment)

Seniority level: Professional Experience

Work model: On-site

Place of work: Elixhausen

Field of work: Other Jobs, Engineering, Technical Jobs

Unfilled vacancies: 1 vacancy unfilled for this position

About the company

Employer: P.G.F. Industry Solutions GmbH

Number of employees: 11 - 30 employees

Locations: Elixhausen

Details about this job

Full Time (Permanent employment)

• Monday to Friday
• 38,5 hours

Place of work

• Elixhausen

Must-have skills

• Quality Assurance
• Regulatory Affairs
• Risk Management
• Document Control
• Internal Auditing

Must-have education

• Degree in a relevant field