Job Description
We are looking for a for a sharp, dedicated, and highly ethical QA Specialist who specialized in Quality Systems & Data to spearhead the digital evolution of our Quality Department. As the QA Specialist, you will be responsible for the strategic implementation of Electronic Quality Management System (e-QMS) and will serve as the primary data controller by ensuring our data integrity. This role is pivotal in ensuring that our quality documentation and data management processes meet the highest standards of accuracy, traceability, and regulatory compliance.
Organizational context & reporting
This position reports directly to the Senior Quality Assurance Manager, working in close synergy with the Quality Assurance and Quality Control teams.
In this role, you will also act as a bridge between quality and other business units to ensure that digital data workflows are standardized and consistently followed across the organization.
Key Responsibilities
Your responsibilities will include, but not be limited to:
- e-QMS Implementation & administration Lead the end-to-end transition from manual/legacy systems to a digital e-QMS, ensuring system configuration aligns with organizational workflows.
- Data Controller & Governance Act as the primary custodian for quality-related documentation. Ensure all data is accurate, traceable, and compliant with relevant industry standards (e.g., ISO 13485).
- Process optimization Analyse existing quality workflows to identify opportunities for digitalization and increased operational efficiency.
- Technical documentation & training develop comprehensive SOPs (Standard Operating Procedures) for digital tools and conduct corporate training sessions to ensure organizational alignment.
- Audit Readiness Maintain an audit-ready digital environment, facilitating both internal and external inspections through meticulous data organization.
Required Qualifications
- Education Bachelor's degree or above. Preferred in Engineering, Quality Assurance field.
- At least 1-2 years of experience working with e-QMS implementation.
- Digital Proficiency Advanced digital literacy is essential. While specific coding knowledge is not required, the candidate must possess an intuitive grasp of software architecture and advanced data management tools (e.g., Excel, ERP, or QMS platforms).
- Communication Proficiency in English (written and verbal) is mandatory.
- Methodological Approach Strong organizational skills with an uncompromising attention to detail and a preference for structured environments.
- Professional Integrity & Ethics A steadfast commitment to transparency and ethical conduct. The candidate must ensure the veracity of data and uphold the highest standards of compliance.
- Accountability & Commitment a results-driven mindset with a strong sense of ownership. We require a professional who is dedicated to the long-term success of the digital transition and the continuous maintenance of system stability.
- Analytical aptitude High cognitive ability characterized by logical reasoning and complex problem-solving skills. The candidate must be able to synthesize intricate data sets and translate quality requirements into efficient digital structures.
Personality
- You approach responsibilities with enthusiasm, and you consistently take the initiative to excel in your work.
- You have an adaptive, can-do attitude, demonstrating both persistence and flexibility when facing challenges.
- You thrive in collaborative settings, working seamlessly within cross-functional teams to drive successful outcomes.
Other information
This position can be either based at our HQ in Stockholm or other locations in Sweden, with a fully remote or hybrid working model.
Why should you join our team?
- We are a global, inclusive team where innovation and creativity are actively encouraged, empowering you to make a meaningful impact.
- An opportunity to develop your career in a dynamic and collaborative environment.
- Join us to embark on a journey committed to delivering innovation and improving lives.
