SaMD (Software as a Medical Device) Quality Assurance Specialist

 

 Coloplast develops products and services that make life easier for people with very personal and private medical conditions. In Coloplast Business Centre we are responsible for global financial operations, orders administration, HR, IT, Legal support, marketing & data analysis activities, and many others. If you have the right profile and the right amount of curiosity and ambition you can be a part of this exciting challenge. Curiosity works here! 

About the department

Portfolio, Transition, and Release Services Department

The Portfolio, Transition, and Release Services department is an integral part of the Digital, Data & IT (DD&IT) organization. Our mission is to support our colleagues across DD&IT by ensuring adherence to procedures, empowering quality, and maintaining compliance. We are dedicated to fostering innovation and driving continuous improvement in all our endeavors.

We collaborate closely with all levels of the business, whether the task at hand involves large-scale programs, projects, continuous improvements, or change requests. Our multidisciplinary team of seven professionals, based in Poland (Szczecin & Warsaw) and Denmark (Copenhagen), brings a diverse range of skills and perspectives to the table.

Leveraging tools like MS Teams for seamless collaboration, we also meet in person quarterly to strengthen our team bonds through workshops and social activities. Together, we strive to grow individually and collectively, upholding the highest professional standards and continuously seeking innovative solutions to enhance our work.

About the job

We are looking for a dedicated and detail-oriented SaMD (Software as a Medical Device) Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that our software products meet stringent quality and regulatory standards. This role involves hands-on quality assurance activities throughout the software development lifecycle, from design to deployment and maintenance, and working closely with cross-functional teams to ensure compliance and quality. 

Your responsibilities

Key Responsibilities

• Quality Standards Implementation: Assist in establishing and implementing quality standards for SaMD products to ensure compliance with regulatory requirements such as ISO 13485 and FDA guidelines.
• Process Monitoring: Support the monitoring of the software development lifecycle, including design, development, testing, and release, to ensure quality and compliance.
• Documentation Support: Assist in building and maintaining a robust documentation structure using validated tools like Veeva.
• Quality Reviews: Conduct quality reviews to ensure compliance with QMS instructions and general quality standards, including templates and Verification and Validation references.
• Expert QA Advisory: Provide expert advice on standards like IEC 62304, acting as a ‘sparring partner’ for the development team.
• Collaborate with IT QA Manager: Work closely with the IT QA Manager to ensure balanced workloads and mutual coverage.
• Product Quality: Continuously assess product quality by evaluating residual defects, particularly during weekly defect review meetings.
• Risk Management: Participate in risk assessments and help manage risk mitigation strategies to ensure the safety and efficacy of the software.
• Audits and Inspections: Assist in preparing for and participating in internal and external audits, ensuring all documentation and processes meet regulatory standards.
• Team Support: Provide support and training to the quality assurance team, fostering a culture of continuous improvement and compliance.

Requirements 

• Educational Background: Master’s degree in computer science, engineering, or a related discipline.
• Experience: Several years of experience from a global organization in quality assurance, particularly in the medical device or healthcare software industry
• Certifications: Certifications such as ISO 13485, FDA 21 CFR Part 11and IEC 62304
• Technical Skills: Proficiency in software quality assurance methodologies, tools, and best practices.
• Regulatory Knowledge: In-depth understanding of regulatory requirements for medical devices, including FDA, ISO, and other relevant standards.
• Analytical Skills: Strong analytical and problem-solving skills to identify and address quality issues effectively.
• Communication Skills: Excellent English verbal and written communication skills to interact with team members, regulatory bodies, and other stakeholders.

• Availability: Available for travelling up to 15 days per year

Competences

• Attention to Detail: Meticulous attention to detail to ensure all aspects of the software meet quality standards.
• Collaboration: Ability to work effectively with cross-functional teams, including development, regulatory, and operations.
• Adaptability: Flexibility to adapt to changing regulatory requirements and project needs.
• Continuous Improvement: Commitment to continuous improvement and staying up-to-date with industry best practices and regulatory changes.
• Risk Management: Proficiency in identifying and mitigating risks associated with software development and deployment.
• Documentation: Expertise in maintaining comprehensive and accurate documentation throughout the software lifecycle.
     

We offer

•    No probation period – long-term contract from the start 

•    Hybrid work possibilities
•    Office hours Mon - Fri
•    International work environment with Scandinavian culture
•    Opportunity to use and develop foreign languages in daily work
•    Fantastic work atmosphere full of respect and partnership 
•    Internal trainings available in our CPBC Academy

 
That's not all! We have even more for you:
•    Modern workplace
•    No dress code zone
•    Great company events
•    Sports card
•    Private medical care
•    Transportation co-funding
•    Restaurant card
•    Holiday bonus and occasional cards
•    Delicious coffee and fresh fruits

 
Recruitment details

Please apply online with your CV in English. 
We will review all applications continuously and invite selected candidates further to the recruitment process. We will close the offer down once we find the best match to the role. 

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Please apply by sending your application in English.

If you are curious like we are, and want to know more about our company go to http://www.cpbc.pl  

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

 Visit us on Coloplast.com.
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