Quality System Specialist
: Job Details :

What this Opportunity Offers

Join a global leader and fast-growing MedTech company

Excellent personal and professional growth opportunity

Competitive salary and excellent benefits

Are You?

Experience in MedTech with single use/disposable products?Great at finding innovative solutions to quality-related challenges?Enjoying root cause analysis and implementing corrective and preventive actions (CAPA)?

Our client, Mermaid Medical, is seeking an experienced Quality System Specialist to support its rapid growth in North America. Mermaid Medical develops, manufactures, and distributes medical devices to hospitals and end users across Europe, Asia and the U.S. Mermaid Medical primarily works within solutions to diseases in the vascular system as well as other devices used in interventional radiology. Founded in Denmark in 2007, Mermaid Medical strives to be the preferred partner for manufacturers as well as hospitals and healthcare professionals to help even more patients. With Nordic roots and headquarters in Denmark, Mermaid Medical values cooperation, helpfulness, and openness. For more information and inspiration visit

About this Position

As a Quality Systems Specialist, your main responsibility is to maintain, improve and develop the Quality Management System, working with corrective actions, and helping reduce failure rates and cost of poor quality. You will also get the opportunity to conduct internal and external audits. You will be working closely with the Quality Assurance team, Regulatory Affairs, and product development managers to further mature and raise the quality of the organization. This role reports directly to the Senior Quality Assurance Manager. Some travel is expected.

Role

Key Responsibilities

Responsible for the Corrective and Preventive Action Process in the e-QMS

Maintain Quality Systems documents, such as SOPs and Work Instructions, in a proactive manner to ensure the QMS is positioned well for the future in the respective area.

Partner with Engineering and Operations to define process improvements.

Conduct Internal Audits.

Support External Audits.

Support incoming and in-process inspection as a Quality Inspector Backup when needed.

Support any complaint and recall activities when needed.

Support Management Review and Data Analysis related to input data for CAPA.

Support Validation and Verification activities when needed.

Assist and support other team members as necessary.

Occasional international travel can be expected as you will be working daily with a global team.

Your Profile

Your Education & Work Experience

• Bachelor's degree in industrial engineering, Quality Engineering, or related field (preferred) and/or medical device experience. 5 years of experience in Quality Systems, Quality Assurance, and Risk Management in the medical device industry
• Knowledge and experience of the relevant regulations preferred, i.e., MDR, FDA, relevant laws, and guidelines, such as MEDDEV, applicable standards, etc.
• Proficient in Microsoft 365

Your Skills & Personality Characteristics

• Detail-oriented, excellent problem-solving and analytical abilities.
• Ability to multitask.
• Great written and verbal communication skills.
• Strong organizational skills.
• Flexible and honest.
• Proactive, take responsibility.
• Positive team player mindset