Quality Engineer - Mermaid Medical Group

What this Opportunity Offers

Join a global leader andfast-growing MedTech company

Excellent personal and professional growth opportunity

Competitive salary and excellent benefits

Are You?

Experienced in the MedTech industry?Great at multitasking and setting priorities?Enjoying validating manufacturing processes, software, and equipment?

Our client, Mermaid Medical, is seeking an experienced Quality Engineer 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 https://www.mermaidmedical.com/

About this Position

As the Quality Engineer, you will be maintaining, improving, and developing our Quality Management System, working with corrective actions and helping reduce failure rates and cost of poor quality, and conducting internal and external audits. You will be working closely with our Quality Assurance, Regulatory Affairs, and Product Development Managers to further mature and raise the quality of our organization. This role reports directly to the Senior Quality Assurance Manager. Travel up to 30% of the time is expected.

Role

Key Responsibilities

• Responsible for leading Non-Conforming Processes which includes investigation and disposition of nonconforming products.
• Conduct Material Review Boards (MRBs) meetings.
• 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.
• Evaluates bioburden testing is completed according to schedule.
• Oversee the Product Release Processes and device history records review.
• Compile QMS Data for Management Review and Data Analysis.
• Support Risk Management, Design Review, and other Device History File-related activities.
• Support Supplier Management Process.
• Support Management Review and Data Analysis related to input data for NC.
• Other typical QE tasks as assigned based on project needs that arise.
• 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 mechanical engineering, Industrial Engineering, or related field.5 years of experience in Quality Systems, Quality Assurance, and Risk Management in the medical device industry or equivalent.
• Knowledge and experience of the relevant regulations preferred, i.e., MDR, FDA, relevant laws, and guidelines, such as MEDDEV, and applicable standards.
• Proficient in Microsoft 365.

Your Skills & Personality Characteristics

• Detail-oriented, excellent problem-solving and analytical abilities.
• Ability to multitask and set priorities.
• Great written and verbal communication skills.
• Flexible and honest.
• Positive team player mindset